Hello,
I hope you're doing well.
My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a CQV Engineer based in Holly Springs, NC with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com OR +1 (732) 737 8381
Job Title: CQV Engineer
Location: Holly Springs, NC
Job Summary
Seeking experienced CQV Engineers to support a large greenfield biopharmaceutical manufacturing project. Candidates should have strong hands-on experience in commissioning, qualification, startup, and validation activities within GMP-regulated environments.
Key Responsibilities
- Execute commissioning, qualification, and startup activities for GMP equipment and utility systems.
- Develop and execute IQ/OQ protocols, test plans, and turnover packages.
- Support startup, troubleshooting, and operational readiness activities.
- Review P&IDs, vendor documents, and system impact assessments.
- Coordinate with engineering, automation, validation, quality, and operations teams.
- Support deviations, change controls, punch list resolution, and compliance activities.
- Participate in FAT/SAT, walkdowns, and mechanical completion activities.
Required Experience
- 5+ years of CQV/startup experience in pharma, biotech, or life sciences.
- Strong greenfield project experience.
- Hands-on experience with critical utilities:
- WFI
- Clean Steam
- HVAC
- Compressed Air
- Purified Water
- CIP/SIP Systems
- Experience with upstream/downstream process equipment.
- Strong GMP documentation and protocol execution skills.
- Ability to work independently in fast-paced project environments.
Preferred Qualifications
- Experience with DeltaV, Rockwell, or similar automation systems.
- Biologics or sterile manufacturing experience preferred.
- Familiarity with Kneat, ValGenesis, or electronic validation systems.
- Bachelor’s degree in Engineering or related field.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381