CQV Engineer: Pharma Validation & Commissioning Specialist

PACIV

Raleigh (NC)

On-site

USD 75,000 - 110,000

Full time

22 hours ago
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Benefits offered by this job

Paid time off
Health insurance premium coverage
Health Savings Account (HSA) with会社Con
401(k) with company match

Job summary

PACIV in Raleigh, NC seeks a CQV Engineer to support commissioning, qualification, and validation of manufacturing systems in regulated pharmaceutical environments. You will help deliver compliant, production-ready assets on high-impact capital projects.

Responsibilities include developing CQV deliverables, risk assessments, test cases, and validation documentation, plus FAT/SAT participation and change management support. Travel up to 40% domestically and internationally.

Qualifications

  • Bachelor's degree in Biomedical or Chemical Engineering.
  • Up to 3 years experience with CQV deliverables and validation activities.
  • Knowledge of validation principles and lifecycle documentation.
  • Strong communication and multi-tasking skills.

Responsibilities

  • Develop and drive CQV deliverables and validation plans.
  • Support API manufacturing equipment, filling operations, packaging systems.
  • Participate in design reviews and FAT/SAT activities.
  • Maintain validation documentation in electronic systems.
  • Assist change management and commissioning activities.
  • Coordinate training and onboarding requirements.

Skills

CQV experience
Validation deliverables
Project management
Regulatory compliance

Education

Bachelor's degree in Biomedical or Chemical Engineering

Job description

PACIV in Raleigh, NC seeks a CQV Engineer to support commissioning, qualification, and validation of manufacturing systems in regulated pharmaceutical environments. You will help deliver compliant, production-ready assets on high-impact capital projects.

Responsibilities include developing CQV deliverables, risk assessments, test cases, and validation documentation, plus FAT/SAT participation and change management support. Travel up to 40% domestically and internationally.

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