JOBSEARCHER

Performance Engineer Full Time

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*