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Senior CQV Lead GMP Biologics Equipment & Utilities

Job in New York, New York County, New York, 10261, USA
Listing for: RSM
Full Time position
Listed on 2026-08-27
Job specializations:
  • Engineering
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below
Position: Senior CQV Lead for GMP Biologics Equipment & Utilities
Location: New York

RSM is seeking a Lead Validation Engineer to oversee GMP equipment installation, commissioning, and qualification for biologics manufacturing systems, spanning upstream and downstream processes. The role ensures safety, on-schedule delivery, and compliance with regulatory and quality requirements.

The candidate will lead cross-functional teams, manage schedules and budgets, and provide regulatory-ready documentation, URSs, FAT/SAT, and change controls as needed.

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Position Requirements
10+ Years work experience
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