What are the responsibilities and job description for the Commissioning, Qualification, and Validation (CQV) Engineer position at Process, Automation & Commissioning Engineers, Inc.?
We are seeking a proactive and detail-oriented CQV Engineer to support our client’s pharmaceutical and life sciences projects in the Raleigh/Durham area. This individual will play a key role in commissioning, qualification, and validation (CQV) activities for equipment and systems. The ideal candidate has a strong work ethic, excellent communication skills, and a great attitude, making them a seamless fit within a dynamic team environment.
Responsibilities
- Lead and support CQV activities for process equipment, utilities, and automation systems, ensuring compliance with cGMP regulations and industry standards.
- Develop and execute commissioning and qualification protocols (IQ/OQ), including documentation preparation, execution, and reporting.
- Conduct risk assessments (FMEA, GMP impact assessments) to support validation strategy development.
- Interface with cross-functional teams (engineering, quality, operations, and project management) to troubleshoot issues and ensure project success.
- Maintain strong documentation and software proficiency, ensuring accurate record-keeping, data analysis, and compliance with regulatory requirements.
- Support and coordinate with vendors and contractors for equipment startup, qualification, and troubleshooting.
- Take a proactive approach to problem-solving and continuously seek process improvements.
- Ensure timely completion of CQV activities to meet project milestones.
- Provide regular updates / deliverable progress to CQV leads and project managers.
- Work with PACE, the client and other CQV resources to ensure site/project standards are met.
- Ensure compliance with relevant client procedures
Qualifications
- ~5 years of experience in CQV projects within the pharmaceutical, biotech, or life sciences industry.
- Experience working in a multi-disciplinary design office or equivalent client team
- Demonstrated CQV experience in client-side, project-team environments.
- Life Sciences experience in CQV projects within biologics, aseptic / sterile processing, and / or secondary applications.
- Site start-up experience preferred
Essential Skills
- Strong knowledge of cGMPs, FDA, EMA, and ISPE guidelines for equipment and systems qualification.
- Hands-on experience with process equipment, clean utilities, HVAC, automation systems, and laboratory instruments.
- Proficiency in CQV documentation tools and software (e.g., Veeva, Kneat, Bluebeam, or similar).
- Excellent verbal and written communication skills with the ability to interact effectively with both technical and non-technical stakeholders.
- Strong analytical, problem-solving, and organizational skills, with a self-driven and proactive mindset.
- Ability to work independently and as part of a team, maintaining a collaborative and solution-focused attitude
Why Join Us
- Opportunity to work with a dynamic, high-performing team in the life sciences industry.
- Be part of impactful pharmaceutical and biotech projects that contribute to healthcare advancements.
- Competitive compensation and professional growth opportunities in a fast-paced environment.