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Commissioning & Qualification Lead - Clean Utilities

Warman O’Brien
Baltimore, MD Full Time | Contractor
POSTED ON 4/3/2025
AVAILABLE BEFORE 5/2/2025

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

 

If you would like to be considered, please apply now to arrange for a confidential discussion with one of our recruiters!

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