What are the responsibilities and job description for the CQV Consultant position at SmartIMS Inc.?
Onsite in Sacramento, California
CQV Consultant .
The selected candidate will be responsible for commissioning, qualification, and validation activities related to GMP utilities, manufacturing equipment, process systems, and supporting infrastructure within a regulated biotech environment.
The role requires strong expertise in qualification lifecycle management, GMP compliance, equipment validation, and cross-functional collaboration with Engineering, Manufacturing, Quality Assurance, and Validation teams.
Computer System Validation (CSV)
- Support CSV activities associated with equipment software, automation systems, and equipment-to-system interfaces.
- Review software configuration documentation and validation evidence.
- Assist in validation of GMP computerized systems associated with manufacturing operations.
Required Qualifications
Education
- Bachelor s degree in engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related discipline.
Experience
- Minimum 5 years of experience in CQV within pharmaceutical, biotechnology, or regulated manufacturing environments.
- Hands-on experience executing IQ/OQ/PQ protocols.
- Experience with GMP manufacturing equipment and utility qualification.
- Exposure to commissioning and startup activities
Regulatory Knowledge
- cGMP
- 21 CFR Part 11
- GAMP 5
- ICH Q9
- ICH Q10