CQV Consultant

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