Documentation & CMMS Operations Specialist (GMP)

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

Job summary

Pfizer’s Pearl River site seeks a systems coordinator for documentation management in manufacturing. You will oversee CMMS, SDS electronic logbooks, MBRs and SOPs to ensure compliant engineering and operations documentation.

The role requires ownership, cross-functional collaboration, and knowledge of cGMP. The position supports audits and ongoing process improvements within a manufacturing environment.

Qualifications

• Associates degree with 5+ years or BA/BS with 2+ years or MBA/MS with relevant experience.
• Strong sense of ownership and accountability.
• Excellent organization and time management skills.
• Ability to collaborate across functions and communicate with leadership.
• Knowledge of cGMP and FDA regulations; data analysis and digital systems.
• Experience using AI tools (ChatGPT, Copilot) for 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 issuance of and reconciliation of cGMP maintenance plans, SOPs, Forms and MBRs.
• Support regulatory/internal audits.

Skills

Ownership & accountability

Organization & time mgmt

Cross-functional collaboration

cGMP & FDA knowledge

Data analysis & digital systems

AI tools (ChatGPT, Copilot)

Education

Associates/Bachelors/MBA/MS

Tools

CMMS

SDS Electronic Logbooks

Master Batch Records System

SOP management system

Job description

Pfizer’s Pearl River site seeks a systems coordinator for documentation management in manufacturing. You will oversee CMMS, SDS electronic logbooks, MBRs and SOPs to ensure compliant engineering and operations documentation.

The role requires ownership, cross-functional collaboration, and knowledge of cGMP. The position supports audits and ongoing process improvements within a manufacturing environment.