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
CQV Engineer in chapel hill at Unknown Company
This position is listed as contract and onsite.