What are the responsibilities and job description for the CQV Engineer position at Insight Global?
Must-Have Qualifications:
- Bachelor’s Degree in Engineering or related technical field
- 1–5 years of experience in CQV, validation, or pharmaceutical/biotech manufacturing
- At least 1 year of hands-on experience in large-scale biotech manufacturing environments
- Experience working with:
- Pumps, bioreactors, or large stainless-steel equipment
- Strong experience with:
- IQ/OQ/PQ execution
- GMP documentation practices
- Ability to troubleshoot equipment and support real-time issues in the field
- Strong communication and cross-functional collaboration skills
Nice-to-Have Skills:
- Experience with Kneat validation software (or willingness to learn)
- Exposure to: Chromatography systems, UF/DF operations
- Background in: Chemical Engineering, Mechanical Engineering, Process Engineering
- Prior experience in startup or commissioning environments
Job Description:
Insight Global is seeking CQV Engineers to support validation and startup activities within its biologics manufacturing facility in Holly Springs, NC. This role is heavily focused on validation execution, protocol development, and hands-on commissioning activities within a fast-paced GMP environment. The team is looking for engineers who are comfortable working both at a desk and in the field, with a strong emphasis on equipment troubleshooting, startup support, and practical problem-solving.
Responsibilities:
- Author and develop validation protocols using standardized templates (IQ/OQ/PQ)
- Drive protocols through cross-functional review and approval with Engineering and Quality
- Execute protocols in the field, including: System walkdowns, Startup testing and shake-down activities, Troubleshooting equipment issues during execution
- Complete post-execution documentation, deviations, and validation reports
- Support commissioning activities including: First-time equipment startup, Equipment stand-up and readiness
- Partner with Engineering, Quality, Automation, and Operations to ensure systems meet GMP and design requirements
- Utilize CMMS/work orders to support equipment startup and commissioning activities
- Maintain strong documentation practices aligned with GMP standards
Salary : $53 - $75