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Commissioning & Qualification Engineer

Company:
Warman OBrien
Location:
Baltimore, MD, 21201
Posted:
April 25, 2025
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Description:

Warman O'Brien are delighted to partner with a Leading Pharmaceutical Company seeking a team of Engineers to support on a long term 12 month extendable project.

We are looking for Commissioning and Qualification Engineers and 4 x Area Leads in following areas: Clean Utilities, HVAC, Project Manager & Scheduler, Process Equipment.

Key Responsibilities:

Develop and execute commissioning protocols (FAT, SAT, IQ, OQ, PQ).

Lead qualification of equipment, utilities, and facilities in GMP-regulated environments.

Perform risk assessments and ensure compliance with regulatory standards (FDA, EMA, GAMP, ISPE).

Review system documentation (P&IDs, wiring diagrams) and participate in system walkdowns.

Collaborate with engineering, manufacturing, and quality teams to support installation and commissioning.

Required Skills & Experience:

5+ years of C&Q experience in Pharmaceuticals, Biotech, or Medical Devices.

Strong knowledge of GMP, FDA, EMA, ISPE, and GAMP regulatory requirements.

Hands-on experience with HVAC, bioreactors, clean utilities, process gases, and environmental monitoring systems.

1099 Contracts

Competitive Hourly Rate

Full time onsite - 40 hours per week

Start Date - April/May 2025

Permanent

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