What are the responsibilities and job description for the CQV Engineer position at PQE Group?
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 2000 employees, 45 nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.
Due to a continuous growth, we are looking for experienced Commissioning, Qualification, and Validation (CQV) Engineers to lead complex projects involving filling lines, clean utility systems, and cleanroom modifications at our pharmaceutical manufacturing facilities in Rocky Mount, NC.
Responsibilities include, but are not limited, to the following:
• Lead CQV activities for new and modified filling lines, including isolator systems
• Develop and execute IQ, OQ, and PQ protocols for filling equipment such as vial washers, depyrogenation tunnels, filling machines, and capping systems
• Perform risk assessments (e.g., FMEA) for filling line modifications and qualifications
• Troubleshoot and resolve technical issues during qualification activities
• Manage CQV processes for clean utility systems, including purified water, Water for Injection (WFI), clean steam, and compressed air
• Collaborate with automation teams on DeltaV system integration and validation
• Ensure compliance with relevant pharmacopeia standards (e.g., USP, EP) for water systems
• Lead qualification efforts for cleanroom modifications and new installations
• Develop and execute protocols for HVAC system performance, including airflow studies and particle counting
• Ensure compliance with ISO 14644 standards and GMP Annex 1 requirements
• Collaborate with cross-functional teams, including engineering, manufacturing, quality assurance, and regulatory affairs
• Manage project timelines, resources, and budgets for CQV activities
• Participate in FAT/SAT activities at equipment vendor sites and on-site
Our ideal candidate should have the following features:
• Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred
• Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry
• In-depth knowledge of cGMP regulations, including EU GMP Annex 1 and FDA aseptic processing guidelines
• Extensive experience with qualification of filling lines, clean utilities, and cleanroom systems
• Proficiency in risk management methodologies (e.g., FMEA, HACCP)
• Strong understanding of aseptic processing and sterilization techniques
• Experience with isolator technology and RABS (Restricted Access Barrier Systems)
• Familiarity with computerized system validation and 21 CFR Part 11 compliance
• Familiarity with GAMP 5 guidelines for computerized systems
• Certification in Lean Six Sigma or other process improvement methodologies
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.
Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
