CQV Engineer (Raleigh-Durham-Chapel Hill Area)

Technical Source is currently in search of a CQV Engineer for a pharmaceutical manufacturing client in the Raleigh-Durham-Chapel Hill Area. This is a long-term contract position that requires on-site work. The qualified candidate should have experience conducting the Commissioning, Qualification, and Validation of Aseptic Formulation/Filling Equipment, Vision Systems, Packaging Equipment, and Utilities/Facilities.

Responsibilities of the CQV Engineer include:

• Develop, execute, and maintain validation documentation throughout the full validation lifecycle.
• Support commissioning, qualification, FATs, SATs, deviations, engineering changes, and Change Controls.
• Author and execute IQ/OQ/PQ and Process Validation protocols and reports.
• Track validation deliverables and provide project status, risks, and escalations to project leadership.
• Utilize electronic validation systems.

Qualifications of the CQV Engineer include:

• Bachelor's degree in engineering or related field.
• 3+ years of CQV experience.
• Experience with aseptic filling, vision inspection, packaging, and facilities/utilities.
• Knowledge of BMS, HVAC, utilities, instrumentation, and GMP facility systems.
• Working knowledge of GMP, FDA, EU Annex 15, GAMP 5, and electronic validation documentation.

*No C2C or Sponsorship is available at this time*

*Compensation will scale based on experience and fit*