CQV Engineer – Facilities, Utilities & Process Systems

Position Summary

Pioneer GMP Consulting is seeking skilled CQV Engineers with 3–7 years of experience to support commissioning, qualification, and validation (CQV) projects across pharmaceutical and biotech facilities in the Southeastern United States. This role will involve executing CQV activities for facilities, utilities, labs, and process systems, ensuring compliance with GMP standards while applying a science-based, risk-based validation approach. The successful candidate will bring both technical expertise and practical experience in regulated environments to ensure systems are safe, compliant, and inspection-ready.

Key Responsibilities

• Execute CQV activities for clean utilities, laboratory systems, process equipment, and facility infrastructure.
  

• Develop, review, and execute IQ/OQ/PQ protocols in line with GMP and regulatory requirements.
  

• Apply risk-based validation methodologies to prioritize critical systems and focus resources efficiently.
  

• Perform environmental qualification activities, including warehouse and controlled environment temperature mapping.
  

• Support startup, troubleshooting, and issue resolution for utility and process systems.
  

• Ensure activities are performed in compliance with GMP, industry guidelines, and site procedures.
  

• Collaborate with engineering, validation, and quality stakeholders to meet project milestones.
  

• Prepare detailed technical documentation, deviations, and final reports to support regulatory inspection readiness.
  

Requirements

• 3–7 years of CQV experience within pharmaceutical, biotech, or life sciences industries.
  

• Strong knowledge of GMP regulations, industry standards, and risk-based validation practices.
  

• Hands-on experience commissioning and qualifying utilities, laboratory systems, or process equipment.
  

• Solid foundation in science or engineering, with the ability to apply technical principles to CQV activities.
  

• Excellent organizational, problem-solving, and communication skills.
  

Qualifications

• Demonstrated success in executing CQV deliverables across a range of facility and process systems.
  

• Experience with science-based and risk-based validation approaches (ICH Q9, ASTM E2500).
  

• Ability to manage individual tasks while contributing to team-based project execution.
  

• Flexibility to work on-site at project locations across the Southeastern U.S.
  

Preferred Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related scientific discipline.
  

• Experience supporting greenfield or large-scale facility startup projects.
  

• Familiarity with aseptic processing systems, laboratory CQV, and building commissioning.
  

• Strong data analysis and statistical evaluation skills.
  

Compensation & Benefits

Competitive hourly/salary rates commensurate with experience. Benefits and per diem/travel allowances may apply depending on assignment.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.