CQV Engineer II — GMP Validation for Life Sciences

IPS - Integrated Project Services, LLC; Emeryville (CA); On-site; USD 96,000 - 129,000; Full time

Job summary

IPS is seeking a CQV Engineer II to join our Emeryville, CA office. You will perform cGMP-based commissioning, qualification, validation, and related consulting services for life sciences facilities while following IPS and client standards.

You will write CQV documents, witness FATs/SATs, execute protocols, perform field activities, and assist in deviations. A BS in Engineering and 2+ years in pharma/biotech/medical device are required.

Qualifications

• BS in Engineering.
• 2+ years of relevant experience in CQV or GMP validation.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.

Responsibilities

• Write C/Q/V documents using IPS templates (e.g., Protocols, Reports, SOPs).
• Attend and witness FATs and SATs as IPS client representative.
• Execute C/Q/V protocols and commissioning activities; verify drawings and data packages.
• Assist deviation investigations and resolve issues during field execution.

Skills

2+ years experience

cGMP knowledge

Documentation writing

Education

Bachelor of Science in Engineering

Tools

FAT/SAT protocols

Job description

IPS is seeking a CQV Engineer II to join our Emeryville, CA office. You will perform cGMP-based commissioning, qualification, validation, and related consulting services for life sciences facilities while following IPS and client standards.

You will write CQV documents, witness FATs/SATs, execute protocols, perform field activities, and assist in deviations. A BS in Engineering and 2+ years in pharma/biotech/medical device are required.