Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.
The HR Compliance Senior Manager ensures completion of all required compliance reporting and partners with Legal on the development of AAP plans and programs. This role also oversees compliance of HR systems and processes with data privacy requirements and SOX controls. The HR Compliance Senior Manager partners with DE&I, Talent Acquisition and Compensation in the development and implementation of compliance-related enterprise workforce analytics.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Endo’s US-based organizations
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
EEO & AAP Subject Matter Expert
§ Timely completion of all government reporting, and partnership with DE&I to ensure compliance for Company’s affirmative action programs and all related federal, state and local EEO requirements, including but not limited to E.O. 11246, Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act to manage risk and exposure.
§ Partner with Legal and external firm to develop AAP plans and programs, guidelines, initiatives, and performance standards and conduct analysis to identify issues and develop responsive action plans.
§ In conjunction with DE&I, and Legal Department, serve as Company’s liaison to AAP/EEO Consultant, U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) for all stages of the compliance review process (e.g., inquiries, requests for information, desk audits, on-site reviews and conciliation process). Conduct internal audits/reviews (at the direction of the Company’s legal counsel) to evaluate AAP compliance.
§ Manage Company response to external audits and requests for EEO/AA information; provide direction to HRBPs, and other stakeholders to document processes, decisions and initiatives as proof of compliance.
o Lead the planning and execution of periodic Self-ID surveys of all US team members, including communications strategy and implementation.
o Assess overall compliance of policies, procedures, websites, data and processes against EEO regulations. Lead efforts to provide accommodations to applicants and ensure accessibility to career sites.
§ Actively maintain knowledge of regulatory processes affecting EEO/AA compliance and develop strategies and actions accordingly. Provide regular communication and training to business entities with respect to EEO/AA issues.
§ Partner with DE&I to provide ongoing training for Talent Acquisition, Compensation and HRBPs on the changing regulatory landscape.
Data/Process Compliance
§ Assess compliance of global HR systems and processes with country-specific data privacy requirements. Oversee initiatives to correct any identified deficiencies.
§ Actively maintain knowledge of evolving data privacy regulations and provide communication and training to the global HR team as needed.
§ Ensure alignment of HR systems and processes with SOX control requirements. Respond to periodic SOX audit requests from internal and external auditors.
Compliance-related Enterprise Workforce Analytics
§ Partner with DE&I and talent acquisition teams to develop and direct compliance-related recruitment strategies, programs and guidelines, with a strong focus on ensuring diverse candidate slates and meeting goals in underrepresented areas. Ongoing monitoring of data to assess effectiveness.
§ Partner with DE&I in the development of various analytics including workforce demographics/composition and pay equity.
§ Partner with HR leadership to report on key Environmental, Social and Governance (ESG) metrics. Assess current metrics and identify opportunities for enhanced analyses.
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor's degree, and some specialized experience and/or training in Labor Relations, HR, or a closely related field.
§ A minimum of 10 years direct experience in EEO matters
§ A minimum of 3-5 years in an EEO management role
§ Government experience in an investigative capacity is strongly preferred
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Expansive knowledge of EEO/Affirmative Action laws and regulations, related employment laws, and government investigative procedures
§ Understanding of the development and implementation of various Human Resources policies that drive our business and ensure a compliant workforce.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Strong analytical and reporting skills
§ Strong project management skills
§ Ability to advise, and interact effectively with, all levels of leadership
§ Excellent organizational skills, with the ability to direct and manage several projects concurrently
§ English language skills - excellent written and verbal communication
§ Ability to prepare and facilitate affirmative action plans
§ High level of interpersonal skills to handle sensitive and confidential situations and documentation
Oct 12, 2021
Full time
The HR Compliance Senior Manager ensures completion of all required compliance reporting and partners with Legal on the development of AAP plans and programs. This role also oversees compliance of HR systems and processes with data privacy requirements and SOX controls. The HR Compliance Senior Manager partners with DE&I, Talent Acquisition and Compensation in the development and implementation of compliance-related enterprise workforce analytics.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Endo’s US-based organizations
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
EEO & AAP Subject Matter Expert
§ Timely completion of all government reporting, and partnership with DE&I to ensure compliance for Company’s affirmative action programs and all related federal, state and local EEO requirements, including but not limited to E.O. 11246, Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act to manage risk and exposure.
§ Partner with Legal and external firm to develop AAP plans and programs, guidelines, initiatives, and performance standards and conduct analysis to identify issues and develop responsive action plans.
§ In conjunction with DE&I, and Legal Department, serve as Company’s liaison to AAP/EEO Consultant, U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) for all stages of the compliance review process (e.g., inquiries, requests for information, desk audits, on-site reviews and conciliation process). Conduct internal audits/reviews (at the direction of the Company’s legal counsel) to evaluate AAP compliance.
§ Manage Company response to external audits and requests for EEO/AA information; provide direction to HRBPs, and other stakeholders to document processes, decisions and initiatives as proof of compliance.
o Lead the planning and execution of periodic Self-ID surveys of all US team members, including communications strategy and implementation.
o Assess overall compliance of policies, procedures, websites, data and processes against EEO regulations. Lead efforts to provide accommodations to applicants and ensure accessibility to career sites.
§ Actively maintain knowledge of regulatory processes affecting EEO/AA compliance and develop strategies and actions accordingly. Provide regular communication and training to business entities with respect to EEO/AA issues.
§ Partner with DE&I to provide ongoing training for Talent Acquisition, Compensation and HRBPs on the changing regulatory landscape.
Data/Process Compliance
§ Assess compliance of global HR systems and processes with country-specific data privacy requirements. Oversee initiatives to correct any identified deficiencies.
§ Actively maintain knowledge of evolving data privacy regulations and provide communication and training to the global HR team as needed.
§ Ensure alignment of HR systems and processes with SOX control requirements. Respond to periodic SOX audit requests from internal and external auditors.
Compliance-related Enterprise Workforce Analytics
§ Partner with DE&I and talent acquisition teams to develop and direct compliance-related recruitment strategies, programs and guidelines, with a strong focus on ensuring diverse candidate slates and meeting goals in underrepresented areas. Ongoing monitoring of data to assess effectiveness.
§ Partner with DE&I in the development of various analytics including workforce demographics/composition and pay equity.
§ Partner with HR leadership to report on key Environmental, Social and Governance (ESG) metrics. Assess current metrics and identify opportunities for enhanced analyses.
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor's degree, and some specialized experience and/or training in Labor Relations, HR, or a closely related field.
§ A minimum of 10 years direct experience in EEO matters
§ A minimum of 3-5 years in an EEO management role
§ Government experience in an investigative capacity is strongly preferred
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Expansive knowledge of EEO/Affirmative Action laws and regulations, related employment laws, and government investigative procedures
§ Understanding of the development and implementation of various Human Resources policies that drive our business and ensure a compliant workforce.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Strong analytical and reporting skills
§ Strong project management skills
§ Ability to advise, and interact effectively with, all levels of leadership
§ Excellent organizational skills, with the ability to direct and manage several projects concurrently
§ English language skills - excellent written and verbal communication
§ Ability to prepare and facilitate affirmative action plans
§ High level of interpersonal skills to handle sensitive and confidential situations and documentation
Reporting to the Senior Litigation Counsel, the Litigation Paralegal is a member of the Legal professional team with primary responsibility for assisting in the management of Endo’s litigation and government investigations. The candidate should be prepared to assist the senior litigation paralegal and in-house counsel with all aspects of litigation management including handling service of process, coordinating discovery and document productions, maintaining case files, calendars and case lists, providing case updates for insurance reporting, and assisting in witness preparation.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Litigation Support
§ Assist with receiving, handling and distributing service of process received at Malvern and coordinate service received at other Endo sites.
§ Assist with administering legal holds including answering questions from employees regarding the legal hold process.
§ Assist with managing complex litigation files, including electronic and hard copy case files and developing and maintaining case charts and summaries.
§ Assist with coordinating with other departments at all Endo locations to locate, gather and organize onsite and offsite documents necessary for discovery requests and deposition preparation.
50%
Document Information Requests
§ Assist with identifying and preparing for production, including any necessary redactions, documents responsive to discovery, subpoena, and diligence requests.
§ Assist with obtaining verifications for discovery responses and pleadings.
25%
Claims Handling
§ Assist with making sure proper notice and reporting is made to the company’s insurers for all litigation matters and assist with obtaining updates in connection insurance policy renewals.
§ Provide timely notice of clams to pharmacovigilance department.
§ Assist with handling of pre-litigation claims, with attorney supervision.
15%
Misc.
§ Assist in updating legal policies and training.
§ Assist with downloading, saving and distributing large files.
§ Provide necessary administrative support to the Litigation Group.
5%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor’s degree required.
§ Paralegal certification required.
§ 3-5 years progressive legal experience in a corporation, pharmaceutical company and/or law firm experience is preferred.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Some familiarity with litigation process.
§ Knowledge on how to conduct fact investigation and legal research.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Strong computer skills including advanced skills with Case Management Software, Adobe Acrobat Pro, MS Office including Word, Excel, PowerPoint, and Outlook and ability to learn new software and systems.
§ Good presentation skills.
§ Strong, professional interpersonal skills, including the ability to communicate effectively with a wide range of individuals and departments.
§ Strong writing and organizational skills, critical thinking, and reasoning abilities are required.
§ Ability to participate on teams with shared responsibility for outcomes and decision-making; resolving conflicts in a constructive manner.
§ Excellent judgment required.
§ Skills and desire to join and fully participate in a diversified, fast-paced multi-dimensional Legal Department.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Business travel less than 10% of time.
Oct 12, 2021
Full time
Reporting to the Senior Litigation Counsel, the Litigation Paralegal is a member of the Legal professional team with primary responsibility for assisting in the management of Endo’s litigation and government investigations. The candidate should be prepared to assist the senior litigation paralegal and in-house counsel with all aspects of litigation management including handling service of process, coordinating discovery and document productions, maintaining case files, calendars and case lists, providing case updates for insurance reporting, and assisting in witness preparation.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Litigation Support
§ Assist with receiving, handling and distributing service of process received at Malvern and coordinate service received at other Endo sites.
§ Assist with administering legal holds including answering questions from employees regarding the legal hold process.
§ Assist with managing complex litigation files, including electronic and hard copy case files and developing and maintaining case charts and summaries.
§ Assist with coordinating with other departments at all Endo locations to locate, gather and organize onsite and offsite documents necessary for discovery requests and deposition preparation.
50%
Document Information Requests
§ Assist with identifying and preparing for production, including any necessary redactions, documents responsive to discovery, subpoena, and diligence requests.
§ Assist with obtaining verifications for discovery responses and pleadings.
25%
Claims Handling
§ Assist with making sure proper notice and reporting is made to the company’s insurers for all litigation matters and assist with obtaining updates in connection insurance policy renewals.
§ Provide timely notice of clams to pharmacovigilance department.
§ Assist with handling of pre-litigation claims, with attorney supervision.
15%
Misc.
§ Assist in updating legal policies and training.
§ Assist with downloading, saving and distributing large files.
§ Provide necessary administrative support to the Litigation Group.
5%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor’s degree required.
§ Paralegal certification required.
§ 3-5 years progressive legal experience in a corporation, pharmaceutical company and/or law firm experience is preferred.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Some familiarity with litigation process.
§ Knowledge on how to conduct fact investigation and legal research.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Strong computer skills including advanced skills with Case Management Software, Adobe Acrobat Pro, MS Office including Word, Excel, PowerPoint, and Outlook and ability to learn new software and systems.
§ Good presentation skills.
§ Strong, professional interpersonal skills, including the ability to communicate effectively with a wide range of individuals and departments.
§ Strong writing and organizational skills, critical thinking, and reasoning abilities are required.
§ Ability to participate on teams with shared responsibility for outcomes and decision-making; resolving conflicts in a constructive manner.
§ Excellent judgment required.
§ Skills and desire to join and fully participate in a diversified, fast-paced multi-dimensional Legal Department.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Business travel less than 10% of time.
The oversight manager will be responsible to evaluate the quality of the monitoring activities to ensure that the rights and well-being of human subjects are protected, implement remedial activities, when necessary, receive feedback from the site on all aspects of study operations, ensure the site is inspection ready, and further establish/improve relationships between Endo and the site. Oversight Manager will also help with oversight of Endo’s vendors and clinical studies.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
§ Develop SOP(s) as needed around oversight activities
§ Identify sites selected for monitoring oversight visit (MOV)
§ Work closely with the R&D Strategy and Operations teams to identify sites to be selected for MOV
§ Author the study specific Monitoring Oversight Plan
§ Conduct Oversight Visits which includes but not limited to review SDV previously completed by CRA, check IP accountability, review CRA queries, review investigator site file, meet with site staff, evaluate quality of monitoring, and evaluate CRA performance
§ Complete report following MOV
§ Escalation of monitoring and quality issues
§ Work with study team on improvements for monitoring/quality issues
§ Perform TMF QC Checks
§ Develop and perform training to improve quality of monitoring
§ Perform site calls to Endo investigative sites to build relationships and help the study teams with escalation/resolution
§ Perform routine Health Assessments to evaluate the health of ongoing clinical studies
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Monitoring Oversight
§ Conduct MOVs
§ Evaluate CRA performance
§ Evaluate quality of monitoring
§ Work with sites/study team to ensure sites are inspection ready
§ Work with study team and implement improvements for monitoring/quality issues
40%
General oversight
§ Health Assessments
§ OSC/ESC attendance/preparation for preferred vendors
§ Site Calls
30%
Training
§ Develop/conduct training to help increase monitoring & vendor quality
§ Develop tools needed to improve monitoring quality
§ Develop training/tools for sites to prepare for site audits
30%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ College degree or RN or higher, preferentially in sciences/medical sciences
§ Minimum of 5 years of clinical monitoring experience
§ Minimum of 8 years of experience in pharmaceutical industry or clinical research site based experience
§ Previous experience managing/overseeing/mentoring CRAs
§ Previous experience developing training/training CRAs
Knowledge
Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Well versed in GCP and applicable FDA/EMEA/ROW regulations
§ Broad and deep understanding of monitoring for clinical trials domestically and globally
§ Knowledgeable in the interaction between functional areas as well as at site level
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Proficient in written and oral communication and experience in presenting to groups.
§ Ability to work with clinical trial and clinical data management systems, MS Office, electronic document management and other web-based systems.
§ Works autonomously under consultative direction toward long range goals.
§ Communicate proactively and appropriately and various levels within the organization and externally.
§ Anticipate problems and innovate effective plans for complex situations.
§ Partner with colleagues to build and maintain strong, collaborative relationships across functional areas within Endo, with Endo alliance partners and external service providers.
§ Ability to prioritize and manage multiple tasks; strength in organization and planning.
§ System experience (e.g., EDC, CTMS, eTMF, IRT)
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Standard office environment and daily commute to assigned office location or regionally based.
§ Business travel ~50%.
Oct 12, 2021
Full time
The oversight manager will be responsible to evaluate the quality of the monitoring activities to ensure that the rights and well-being of human subjects are protected, implement remedial activities, when necessary, receive feedback from the site on all aspects of study operations, ensure the site is inspection ready, and further establish/improve relationships between Endo and the site. Oversight Manager will also help with oversight of Endo’s vendors and clinical studies.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
§ Develop SOP(s) as needed around oversight activities
§ Identify sites selected for monitoring oversight visit (MOV)
§ Work closely with the R&D Strategy and Operations teams to identify sites to be selected for MOV
§ Author the study specific Monitoring Oversight Plan
§ Conduct Oversight Visits which includes but not limited to review SDV previously completed by CRA, check IP accountability, review CRA queries, review investigator site file, meet with site staff, evaluate quality of monitoring, and evaluate CRA performance
§ Complete report following MOV
§ Escalation of monitoring and quality issues
§ Work with study team on improvements for monitoring/quality issues
§ Perform TMF QC Checks
§ Develop and perform training to improve quality of monitoring
§ Perform site calls to Endo investigative sites to build relationships and help the study teams with escalation/resolution
§ Perform routine Health Assessments to evaluate the health of ongoing clinical studies
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Monitoring Oversight
§ Conduct MOVs
§ Evaluate CRA performance
§ Evaluate quality of monitoring
§ Work with sites/study team to ensure sites are inspection ready
§ Work with study team and implement improvements for monitoring/quality issues
40%
General oversight
§ Health Assessments
§ OSC/ESC attendance/preparation for preferred vendors
§ Site Calls
30%
Training
§ Develop/conduct training to help increase monitoring & vendor quality
§ Develop tools needed to improve monitoring quality
§ Develop training/tools for sites to prepare for site audits
30%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ College degree or RN or higher, preferentially in sciences/medical sciences
§ Minimum of 5 years of clinical monitoring experience
§ Minimum of 8 years of experience in pharmaceutical industry or clinical research site based experience
§ Previous experience managing/overseeing/mentoring CRAs
§ Previous experience developing training/training CRAs
Knowledge
Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Well versed in GCP and applicable FDA/EMEA/ROW regulations
§ Broad and deep understanding of monitoring for clinical trials domestically and globally
§ Knowledgeable in the interaction between functional areas as well as at site level
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Proficient in written and oral communication and experience in presenting to groups.
§ Ability to work with clinical trial and clinical data management systems, MS Office, electronic document management and other web-based systems.
§ Works autonomously under consultative direction toward long range goals.
§ Communicate proactively and appropriately and various levels within the organization and externally.
§ Anticipate problems and innovate effective plans for complex situations.
§ Partner with colleagues to build and maintain strong, collaborative relationships across functional areas within Endo, with Endo alliance partners and external service providers.
§ Ability to prioritize and manage multiple tasks; strength in organization and planning.
§ System experience (e.g., EDC, CTMS, eTMF, IRT)
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Standard office environment and daily commute to assigned office location or regionally based.
§ Business travel ~50%.
The Utilities and Facilities Technician will assist in the operation and maintenance of the Horsham facilities and utilities, perform routine building and utility maintenance, and provide on-call response to respond to security and building alarms.
Manufacturing and Horsham Campus
§ Assist Utilities & Facilities Services/Maintenance Supervisor in responding to building / security alarms 24 hours per day, 7 days per week plus occasional emergencies. Individual will be part of the on-call rotation and will be required to respond to off-hours alarm per the department schedule.
15%
§ Perform preventive maintenance and make repairs to the facility and support equipment including but not limited to: administrative areas, building grounds, production, warehouse, laboratory, restrooms, cafeteria, emergency showers, toilets, sprinkler system, etc. Help maintain utility equipment as required to support operations.
15%
§ Collect hazard waste daily, identify, and stage in the holding area for pick-up. Escort Iron Mountain for weekly document destruction pick-ups.
10%
§ Work with Facilities Services/Maintenance with the moving and installation supervision of major laboratory equipment when needed
§ Conduct daily utility rounds and report findings
20%
§ Attend training seminars and courses as required.
5%
§ Oversee Janitorial Management Inc.
5%
§ Site Safety Support program. Participate in audits and safety committee meetings. Serve on the spill team for chemical spills. Maintain spill kits in ready condition.
5%
§ Author and revise Facility Standard Operating Procedures as required.
5%
§ Assist with Building Renovations including moving equipment, painting walls, minor repairs, and overseeing contractors.
10%
§ Coordinate with service contractors and oversee work to completion.
10%
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ 2 year Degree, technical school degree or equivalent experience. High school diploma or equivalent required.
§ Experience as a Maintenance Mechanic, Facilities Technician, or appropriate trade (2 years minimum).
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Experience working in a GMP environment and completion of GMP documentation.
§ OSHA Safe Work Practices.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Good mechanical / carpentry skills.
§ Documentation skills.
§ Good communication and organizational skills.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Must be able to lift 50 pounds.
§ Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods.
§ Operate computer controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal.
§ Required to work around live electrical circuits and mechanical devices in the execution of their duties.
Oct 12, 2021
Full time
The Utilities and Facilities Technician will assist in the operation and maintenance of the Horsham facilities and utilities, perform routine building and utility maintenance, and provide on-call response to respond to security and building alarms.
Manufacturing and Horsham Campus
§ Assist Utilities & Facilities Services/Maintenance Supervisor in responding to building / security alarms 24 hours per day, 7 days per week plus occasional emergencies. Individual will be part of the on-call rotation and will be required to respond to off-hours alarm per the department schedule.
15%
§ Perform preventive maintenance and make repairs to the facility and support equipment including but not limited to: administrative areas, building grounds, production, warehouse, laboratory, restrooms, cafeteria, emergency showers, toilets, sprinkler system, etc. Help maintain utility equipment as required to support operations.
15%
§ Collect hazard waste daily, identify, and stage in the holding area for pick-up. Escort Iron Mountain for weekly document destruction pick-ups.
10%
§ Work with Facilities Services/Maintenance with the moving and installation supervision of major laboratory equipment when needed
§ Conduct daily utility rounds and report findings
20%
§ Attend training seminars and courses as required.
5%
§ Oversee Janitorial Management Inc.
5%
§ Site Safety Support program. Participate in audits and safety committee meetings. Serve on the spill team for chemical spills. Maintain spill kits in ready condition.
5%
§ Author and revise Facility Standard Operating Procedures as required.
5%
§ Assist with Building Renovations including moving equipment, painting walls, minor repairs, and overseeing contractors.
10%
§ Coordinate with service contractors and oversee work to completion.
10%
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ 2 year Degree, technical school degree or equivalent experience. High school diploma or equivalent required.
§ Experience as a Maintenance Mechanic, Facilities Technician, or appropriate trade (2 years minimum).
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Experience working in a GMP environment and completion of GMP documentation.
§ OSHA Safe Work Practices.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Good mechanical / carpentry skills.
§ Documentation skills.
§ Good communication and organizational skills.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Must be able to lift 50 pounds.
§ Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods.
§ Operate computer controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal.
§ Required to work around live electrical circuits and mechanical devices in the execution of their duties.
The Maintenance Technician position will assist in performing corrective and preventative maintenance procedures for plant utilities and manufacturing equipment such as fermenters, process vessels, purification equipment, autoclaves, component washers, and other ancillary manufacturing equipment. In addition, this position will assist with troubleshooting equipment issues and coordinating maintenance with support from contract services. This position supports the Horsham manufacturing facility and labs, Horsham warehouse, and the Rye manufacturing facility.
· Operate, maintain, and repair plant utilities as follows: Air handling equipment and systems; Air conditioning and refrigeration equipment and systems; Boilers (steam and hot water), plant steam, and plant hot water; Chillers and chilled water systems; Air compressors, air dryers, and compressed air systems; Nitrogen system; Domestic hot and cold water system; Natural gas systems; USP Purified Water and Water for Injection (WFI) generation and distribution systems; Clean steam generator and clean steam systems; Plant sewer and waste neutralization systems.
· Perform maintenance and escort contractors as needed.
· Perform maintenance and repair of major laboratory equipment and GMP manufacturing equipment
· Initiate purchase requisitions for materials needed for repair, PM, or consumed during the performance of duties.
· Support preventative maintenance activities as defined by specific equipment requirements.
25%
· Cross train and serve as back-up for routine facility maintenance activities including hazardous waste collection, daily boiler chemical treatment and chemical additions, etc.
10%
· Operate the Siemens and Johnson Controls Building Automation Systems.
10%
· Support Calibration program by assisting calibration personnel as needed.
10%
· Assist with daily monitoring of critical and plant utilities serving the GMP manufacturing plant.
10%
Assist Utilities & Facilities/Maintenance Management in responding to building / security alarms 24 hours per day, 7 days per week plus occasional emergencies. Individual will be part of the on-call rotation and will be required to respond to off-hours alarm per the department schedule.
10%
· Assist in troubleshooting mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs.
5%
· Attend training seminars and courses as required.
5%
· Member of the Safety Committee.
5%
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ 2 year Degree, technical school degree or equivalent experience. High school diploma or equivalent required.
§ HVAC Repair Training preferred.
§ General electrical wiring/installation training, preferred.
§ Minimum 2 years’ experience as a Maintenance Mechanic, Facilities Technician, or with an equivalent trade.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Experience working in a GMP environment and completion of GMP documentation.
§ OSHA safe work practices.
§ Building Management System Experience (Siemens, Johnson Controls) a plus.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Good troubleshooting skills- electrical / mechanical.
§ GMP documentation skills.
§ Must be able to coordinate multiple contract services simultaneously.
§ Good communication and organizational skills.
§ Proficient in all Microsoft Office applications.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Must be able to lift 50 pounds.
§ Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods.
§ Operate computer controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal.
§ Required to work around live electrical circuits and mechanical devices in the execution of their duties.
Oct 12, 2021
Full time
The Maintenance Technician position will assist in performing corrective and preventative maintenance procedures for plant utilities and manufacturing equipment such as fermenters, process vessels, purification equipment, autoclaves, component washers, and other ancillary manufacturing equipment. In addition, this position will assist with troubleshooting equipment issues and coordinating maintenance with support from contract services. This position supports the Horsham manufacturing facility and labs, Horsham warehouse, and the Rye manufacturing facility.
· Operate, maintain, and repair plant utilities as follows: Air handling equipment and systems; Air conditioning and refrigeration equipment and systems; Boilers (steam and hot water), plant steam, and plant hot water; Chillers and chilled water systems; Air compressors, air dryers, and compressed air systems; Nitrogen system; Domestic hot and cold water system; Natural gas systems; USP Purified Water and Water for Injection (WFI) generation and distribution systems; Clean steam generator and clean steam systems; Plant sewer and waste neutralization systems.
· Perform maintenance and escort contractors as needed.
· Perform maintenance and repair of major laboratory equipment and GMP manufacturing equipment
· Initiate purchase requisitions for materials needed for repair, PM, or consumed during the performance of duties.
· Support preventative maintenance activities as defined by specific equipment requirements.
25%
· Cross train and serve as back-up for routine facility maintenance activities including hazardous waste collection, daily boiler chemical treatment and chemical additions, etc.
10%
· Operate the Siemens and Johnson Controls Building Automation Systems.
10%
· Support Calibration program by assisting calibration personnel as needed.
10%
· Assist with daily monitoring of critical and plant utilities serving the GMP manufacturing plant.
10%
Assist Utilities & Facilities/Maintenance Management in responding to building / security alarms 24 hours per day, 7 days per week plus occasional emergencies. Individual will be part of the on-call rotation and will be required to respond to off-hours alarm per the department schedule.
10%
· Assist in troubleshooting mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs.
5%
· Attend training seminars and courses as required.
5%
· Member of the Safety Committee.
5%
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ 2 year Degree, technical school degree or equivalent experience. High school diploma or equivalent required.
§ HVAC Repair Training preferred.
§ General electrical wiring/installation training, preferred.
§ Minimum 2 years’ experience as a Maintenance Mechanic, Facilities Technician, or with an equivalent trade.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Experience working in a GMP environment and completion of GMP documentation.
§ OSHA safe work practices.
§ Building Management System Experience (Siemens, Johnson Controls) a plus.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Good troubleshooting skills- electrical / mechanical.
§ GMP documentation skills.
§ Must be able to coordinate multiple contract services simultaneously.
§ Good communication and organizational skills.
§ Proficient in all Microsoft Office applications.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Must be able to lift 50 pounds.
§ Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods.
§ Operate computer controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal.
§ Required to work around live electrical circuits and mechanical devices in the execution of their duties.