CAI

Senior Validation Engineer

CAI

full-time

Posted on:

Location Type: Office

Location: Charlottesville • Virginia • 🇺🇸 United States

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Salary

💰 $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

Applicant Tracking System 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