Sr Associate Operations & Engineering Documentation
About The Position
The Sr Associate Operations & Engineering Documentation is a key member of the Pearl River team, accountable for coordinating and managing documentation and documentation systems at the site. The role coordinates engineering and operations documentation systems, including the Computerized Maintenance Management System (CMMS), the Electronic Logbooks System (SDS), Master Batch Records, and Standard Operating Procedures. The position supports pharmaceutical and biotechnology manufacturing and associated manufacturing equipment. The role works across Operations, Technical Services, Engineering, Supply Chain, Quality Control, and Quality Assurance to support compliant and timely delivery and reconciliation of manufacturing and engineering/maintenance documentation. It also supports regulatory and internal audits. The position is based on premise and requires aseptic/personnel safety gowning. Occasional off-hours work, including evenings and weekends, may be needed.
Requirements
- Associate degree and 5 or more years of experience, bachelor's degree and 2 or more years of experience, or MBA/MS with any years of relevant experience.
- Strong ownership and accountability; ability to lead change with agility, optimism, and innovation.
- Excellent organization and time-management skills.
- Ability to collaborate effectively within and across functions and articulate issues and solutions to the PCT and senior management.
- Knowledge and experience with cGMP and FDA rules and regulations.
- Proficiency in data analysis and trend monitoring, with knowledge and experience using digital systems in the pharmaceutical industry.
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity.
- Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
- Permanent work authorization in the United States; U.S. work visa sponsorship is not available.
Nice To Haves
- Experience in pharmaceutical or biotechnology manufacturing and with associated manufacturing equipment.
Responsibilities
- Develop CMMS data elements to support engineering and maintenance, including equipment details, maintenance plans, maintenance schedules, and work order task plans.
- Administer the CMMS.
- Author, review, and approve Master Production Batch Records to support manufacturing operations.
- Author, review, and approve electronic logbooks and logbook forms in SDS.
- Author, review, and approve standard operating procedures supporting engineering and manufacturing operations.
- Manage Change Requests, Change Notices, and periodic reviews of production and engineering documentation.
- Coordinate commitment and quality drivers for MBR, forms, maintenance tasks, and SOP updates to ensure updates are coordinated and efficiently implemented.
- Review and file executed maintenance and production documents in coordination with the QARM documentation group.
- Manage and review data in PGS electronic documentation systems.
- Coordinate issuance and reconciliation of cGMP maintenance plans, SOPs, forms, and MBRs.
- Support regulatory and internal audits.
- Coordinate documentation deliverables across matrixed functions and project teams of up to 5–10 colleagues.
Benefits
- 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
- Paid vacation, holidays, and personal days.
- Paid caregiver/parental and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 10% of base salary.
- Relocation assistance may be available based on business needs and/or eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
