Sr Associate Operations & Engineering Documentation
About The Position
The Sr Associate Operations & Engineering Documentation is a key member of the Pearl River team, responsible for coordinating and managing site documentation and documentation systems. 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 requires experience in pharmaceutical or biotechnology manufacturing and associated manufacturing equipment. The role supports engineering, maintenance, and manufacturing operations by administering documentation systems, developing and maintaining system data, authoring and approving controlled documents, coordinating documentation updates, and supporting regulatory and internal audits. It works across site functions to ensure documentation is compliant, timely, and reconciled. The position is on premise and may occasionally require work outside normal hours, including evenings and weekends; aseptic and personnel-safety gowning is required. The annual base salary range is $82,700 to $137,900, and the position is eligible for Pfizer’s Global Performance Plan with a 10% bonus target. Benefits include a 401(k) plan with Pfizer matching contributions and an additional retirement savings contribution, paid vacation, holidays and personal days, paid caregiver/parental and medical leave, and medical, prescription drug, dental, and vision coverage. Relocation assistance may be available based on business needs and/or eligibility. Candidates must have permanent U.S. work authorization; visa sponsorship is unavailable.
Requirements
- Associate degree and 5+ years of experience, or BA/BS and 2+ years of experience, or MBA/MS with any years of relevant experience.
- Experience in pharmaceutical or biotechnology manufacturing and associated manufacturing equipment.
- Knowledge and experience with cGMP and FDA rules and regulations.
- Proficiency in data analysis and trend monitoring, and knowledge and experience with digital systems used 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 using these tools to improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
- Strong ownership and accountability, with the ability to lead change with agility, optimism, and innovation.
- Excellent organization and time-management skills.
- Ability to collaborate effectively within and across functions and communicate issues and solutions to the PCT and senior management.
- Permanent work authorization in the United States; U.S. work visa sponsorship is not available.
- Sharp focus, practicality, and discipline.
- Ability to meet aseptic and personnel-safety gowning requirements.
Responsibilities
- Develop CMMS data elements supporting engineering and maintenance, including equipment details, maintenance plans and schedules, and work-order task plans.
- Administer the CMMS.
- Author, review, and approve Master Production Batch Records supporting 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 quality commitments and drivers for MBR, forms, maintenance tasks, and SOP updates to ensure required 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 Operations, Technical Services, Engineering, Supply Chain, QC, and QA, and with 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, holiday, 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 10% bonus target
- 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
