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Commissioning & Qualification Lead - Clean Utilities

Company:
Warman OBrien
Location:
Baltimore, MD, 21201
Posted:
April 22, 2025
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Description:

C&Q Lead - Clean Utilities (Pharma/Biotech)

Warman O'Brien is delighted to partner with a Leading Pharmaceutical Company seeking an experienced Commissioning & Qualification (C&Q) Engineer to support a long-term, 12-month extendable project. Our client is seeking a Clean Utilities Lead to support GMP manufacturing projects.

Responsibilities:

Lead C&Q activities for Water for Injection (WFI) and Process Compressed Air systems.

Develop and execute qualification strategies in compliance with cGMP and regulatory standards.

Author, review, and approve C&Q protocols, reports, and risk assessments.

Oversee Design Reviews (DR), Design Qualification (DQ), and System Risk Assessments.

Support regulatory inspections and audits related to clean utility systems.

Experience & Skills:

10+ years of C&Q experience in pharmaceutical or biotech industries.

Expertise in WFI, clean utilities, and Process Compressed Air systems.

Strong knowledge of FDA, EMA, and industry standards for clean utility qualification.

1099 Contract

Competitive Hourly Rate

Full time onsite - 40 hours per week

Start Date - April/May 2025

Full Time

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