Intellectt Inc
Equipment Validation Engineer
Intellectt Inc, San Francisco, California, United States, 94199
Overview
Job Title: CQV Engineer Long Term Contract We are seeking experienced CQV Engineers to support commissioning, qualification, and validation activities for biotech/pharma manufacturing facilities. The ideal candidate will have a strong background in process systems, utilities, and equipment qualification within GMP-regulated environments. Responsibilities
Execute Commissioning, Qualification, and Validation (CQV) protocols for equipment, utilities, and systems in compliance with GMP requirements. Develop, review, and execute documentation such as URS, FAT, SAT, IQ, OQ, and PQ. Support start-up and qualification of process systems including bioreactors, chromatography skids, CIP/SIP systems, autoclaves, and clean utilities. Coordinate with engineering, automation, and operations teams to ensure systems are properly commissioned and validated. Conduct impact assessments, risk analyses, and change control evaluations. Generate and maintain validation documentation and reports ensuring regulatory compliance. Support audits, inspections, and deviation investigations. Ensure project timelines and deliverables are met according to schedule. Qualifications
Bachelor’s degree in Engineering, Biotechnology, Chemical Engineering, or related field. 5–6 years of hands-on experience in CQV roles within pharmaceutical or biotech manufacturing. Proven experience with GMP, FDA, and regulatory compliance standards. Proficiency in equipment/system qualification and validation lifecycle documentation. Strong understanding of ISPE Baseline Guides, ASTM E2500, and related industry standards. Excellent technical writing, analytical, and communication skills. Ability to work independently and collaboratively across cross-functional teams.
#J-18808-Ljbffr
Job Title: CQV Engineer Long Term Contract We are seeking experienced CQV Engineers to support commissioning, qualification, and validation activities for biotech/pharma manufacturing facilities. The ideal candidate will have a strong background in process systems, utilities, and equipment qualification within GMP-regulated environments. Responsibilities
Execute Commissioning, Qualification, and Validation (CQV) protocols for equipment, utilities, and systems in compliance with GMP requirements. Develop, review, and execute documentation such as URS, FAT, SAT, IQ, OQ, and PQ. Support start-up and qualification of process systems including bioreactors, chromatography skids, CIP/SIP systems, autoclaves, and clean utilities. Coordinate with engineering, automation, and operations teams to ensure systems are properly commissioned and validated. Conduct impact assessments, risk analyses, and change control evaluations. Generate and maintain validation documentation and reports ensuring regulatory compliance. Support audits, inspections, and deviation investigations. Ensure project timelines and deliverables are met according to schedule. Qualifications
Bachelor’s degree in Engineering, Biotechnology, Chemical Engineering, or related field. 5–6 years of hands-on experience in CQV roles within pharmaceutical or biotech manufacturing. Proven experience with GMP, FDA, and regulatory compliance standards. Proficiency in equipment/system qualification and validation lifecycle documentation. Strong understanding of ISPE Baseline Guides, ASTM E2500, and related industry standards. Excellent technical writing, analytical, and communication skills. Ability to work independently and collaboratively across cross-functional teams.
#J-18808-Ljbffr