Pharma Documentation & CMMS Lead

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

Benefits offered by this job

Annual bonus 10%

Comprehensive benefits and PTO

Job summary

Pfizer Pearl River site seeks a system coordinator for documenting management systems (CMMS, SDS electronic logs, Master Batch records and SOPs) to support manufacturing and engineering operations. You will develop data elements, administer CMMS, and ensure compliant, coordinated documentation across QA, QC, EHS, and Manufacturing.

Strong knowledge of cGMP and FDA regulations, data analysis, and experience with AI tools for problem solving are required.

Qualifications

• Associate degree with 5 years of experience, or BA/BS with 2 years, or MBA/MS with relevant experience.
• Strong ownership, accountability, and agile change leadership.
• Excellent organization and time management skills.
• Ability to collaborate across functions and communicate with PCT and senior management.
• Knowledge of cGMP and FDA regulations.

Responsibilities

• Develops data elements in CMMS for engineering/maintenance, including equipment details, maintenance plans, schedules, and work orders.
• Administers CMMS system.
• Authors/reviews/approves Master Production Batch Records.
• Authors/reviews/approves electronic logbooks and SDS logbooks.
• Authors/reviews/approves SOPs for engineering/manufacturing.
• Manages Change Requests/Notices and periodic documentation reviews.
• Coordinates updates to MBR, forms, maintenance tasks, and SOPs.
• Reviews and files documents with QARM.
• Manages data in PGS electronic documentation systems.
• Coordinates issueing/reconciliation of CGMP docs.

Skills

Data analysis

Trend monitoring

AI tools familiarity

Education

Associate Degree

BA/BS

MBA/MS

Tools

CMMS

Electronic Logbooks System (SDS)

MBR/SOP documentation tooling

Job description

Pfizer Pearl River site seeks a system coordinator for documenting management systems (CMMS, SDS electronic logs, Master Batch records and SOPs) to support manufacturing and engineering operations. You will develop data elements, administer CMMS, and ensure compliant, coordinated documentation across QA, QC, EHS, and Manufacturing.

Strong knowledge of cGMP and FDA regulations, data analysis, and experience with AI tools for problem solving are required.