What are the responsibilities and job description for the CQV Engineer position at United Pharma Technologies Inc?
Job Title: CQV Engineer
Location: Rocky Mount, NC
Job Description
Seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineer to lead projects involving filling lines, clean utility systems, and cleanroom modifications in pharmaceutical manufacturing. The ideal candidate will ensure regulatory compliance and operational excellence in a GMP environment.
Key Responsibilities
- Lead CQV activities for filling lines, clean utilities, and cleanrooms.
- Develop and execute IQ, OQ, and PQ protocols for equipment and systems.
- Perform risk assessments and troubleshoot technical issues.
- Manage validation of purified water, WFI, clean steam, and compressed air systems.
- Ensure compliance with ISO 14644, GMP Annex 1, and pharmacopeia standards.
- Generate comprehensive validation documentation and reports.
- Collaborate with engineering, manufacturing, QA, and regulatory teams.
- Oversee project timelines, budgets, and FAT/SAT activities.
Qualifications and Skills
- Bachelor's in Engineering, Life Sciences, or related field (advanced degree preferred).
- 5 years in CQV within pharmaceutical or biotechnology industries.
- Expertise in cGMP regulations, aseptic processing, and sterilization techniques.
- Experience with isolator technology, RABS, and computerized system validation.
- Strong technical writing, problem-solving, and communication skills.
Preferred Qualifications
- Familiarity with GAMP 5, Lean Six Sigma, and continuous manufacturing.
- Experience with single-use technologies in biopharmaceutical manufacturing.
