CQV Engineer
Full-time
Technical Source
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*
Vacancy posted 4 days ago
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