Process Engineer
PSC Biotech Corporation
Senior Validation Engineer
CAI
full-time
Posted on:
Location Type: Office
Location: Charlottesville • Virginia • 🇺🇸 United States
Visit company websiteSalary
💰 $87,100 - $94,600 per year
Job Level
Senior
About the role
- Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety
- Deliver C&Q activities in alignment with project schedules
- Track and report progress of CQV efforts
- Support the generation and review of C&Q procedures and revise qualification-related documents including SOPs, master plans, and execution plans
- Assist with CQV review and qualification of equipment design and support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities
- Coordinate with project contractors and equipment vendors to execute required testing
- Support planning of commissioning spares and consumables, allocate project resources, and coordinate support and logistics during CQV execution
Requirements
- Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
- 3+ years of related experience in the Pharmaceutical/Life Sciences industry
- Essential experience in a GMP (Good Manufacturing Practice) environment
- Outstanding oral and written communication skills
- Strong problem-solving abilities
- Customer-focused mindset
- Willingness and flexibility to travel throughout the U.S. and potentially internationally
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CommissioningQualificationValidationCQV proceduresSOPsmaster plansexecution plansFATsIQOQ
Soft skills
oral communicationwritten communicationproblem-solvingcustomer-focusedflexibilitywillingness to travel
