Senior Pharma Operations & Engineering Documentation Lead

Pfizer Inc; Pearl River (NY); On-site; USD 83,000 - 138,000; Full time

Job summary

Pfizer Inc. in Pearl River, NY seeks a Documentation System Coordinator to manage and coordinate site documentation systems for engineering and operations.

You will handle CMMS data elements, maintenance plans, SOPs, MBRs and electronic logbooks, ensuring alignment with regulatory requirements and site needs. You will lead change control, support audits, and collaborate across functions with a strong emphasis on cGMP compliance and data-driven decision making.

Qualifications

• Associates degree with 5+ years experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience.
• Strong sense of ownership and accountability; lead change with agility, optimism and innovation.
• Excellent organization and time management skills.
• Demonstrated ability to collaborate across functions and with senior management.
• Knowledge and experience of cGMP and FDA rules and regulations.
• Proficiency in data analysis and trend monitoring; familiarity with digital systems in pharma.
• Experience using AI tools (e.g., ChatGPT, Copilot) to support problem solving.

Responsibilities

• Develops data elements in the CMMS for support of engineering and maintenance including equipment details, maintenance plans, maintenance schedules and work order task plans.
• Administers CMMS system.
• Authors, reviews and approves Master Production Batch Records to support manufacturing operations.
• Authors, reviews and approves electronic logbooks and logbook forms in SDS.
• Authors, reviews and approves standard operating procedures to support engineering and manufacturing operations.
• Manages Change Requests, Change Notices and Periodic Review of production and engineering documentation.
• Coordinates commitment and quality drivers for MBR, FORMS, Maintenance Tasks and SOP updates to ensure updates are coordinated and implemented.
• Reviews and files executed maintenance and production documents with QARM.
• Manages and reviews data in PGS electronic documentation systems.
• Coordinates issuance of and reconciliation of cgMP maintenance plans, SOPs, forms and MBRs; supports audits.

Skills

CMMS administration

Documentation control

Data analysis

Change control

Education

Associates degree

BA/BS degree

MBA/MS

Tools

SDS electronic logbooks

CGMP documentation systems

Job description

Pfizer Inc. in Pearl River, NY seeks a Documentation System Coordinator to manage and coordinate site documentation systems for engineering and operations.

You will handle CMMS data elements, maintenance plans, SOPs, MBRs and electronic logbooks, ensuring alignment with regulatory requirements and site needs. You will lead change control, support audits, and collaborate across functions with a strong emphasis on cGMP compliance and data-driven decision making.