Facilities Supervisor – cGMP Documentation, Deviations & CAPA

Job Title: Facilities Supervisor – cGMP Documentation, Deviations & CAPA
Location: Piscataway, NJ
Type: Direct Hire
Compensation: $80-85k
Hours: Mon-Fri 1st shift but must be willing to work all shifts based on business needs

Responsibilities

• Develops and manages projects required to provide equipment supporting the business plan.
• Coordinates scheduled and emergency maintenance, repair, and improvements to equipment.
• Manages ERP work order system and assigns work orders and PM’s to staff.
• Identifies future maintenance and/or equipment resources required to meet the business plan.
• Orders parts for preventative maintenance, work orders, routine jobs, and emergency repairs.
• Supports the development of the Preventative Maintenance Program to ensure proper equipment maintenance, efficiency, and FDA compliance.
• Participates in the Quality Improvement Program by performing investigations, writing response reports, and implementing corrective actions for CAPA’s within Production Maintenance responsibilities.

Requirements

• Bachelor's degree in mechanical, chemical, or related engineering field.
• Must have experience with opening, closing, writing deviations related to facilities in a GMP environment
• 8+ years of facilities experience in the pharmaceutical industry (close acceptable).
• 5+ years of work experience in a cGMP environment.
• Willingness to work all shifts based on business needs; 1st shift initially.
• Computer proficiency.
• Biologics or related facilities experience preferred.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific