Tap Growth ai
Engineer, QA Validation/ Validation Engineer (QA/GMP)
Tap Growth ai, Novato, California, United States, 94949
Engineer, QA Validation
We are seeking to hire an Engineer, QA Validation in Novato, CA.
Location Novato, United States
Work Mode Work From Office
Role Engineer, QA Validation
Pay Scale $85,363 – $106,716 (Dependent on Experience)
What You’ll Do
Review and approve user requirement specifications, automation functional requirement specifications, and software design documentation for automated facilities, utilities, and equipment.
Review and approve FATs, SATs, commissioning, and automation acceptance testing, qualification (IQ, OQ & PQ) protocols, validation discrepancy reports, and final report packages for facilities, utilities, and equipment to support implementation of new systems, changes, revalidation, and periodic review of existing systems.
Implement data integrity in a GMP environment.
Define and document the data life cycle for GMP systems.
Perform data integrity risk assessment and develop mitigation strategies to address risks.
What We’re Looking For
BS in a technical discipline (Engineering, physical, or biological sciences) or Equivalent experience.
Training in project management is preferred.
5+ years of experience in a GMP regulated environment (Biotech or equivalent) with exhibited knowledge or proficiency in engineering.
Experience in the review and approval of Validation and Qualification lifecycle documentation such as URS, IQ/OQ/PQ, commissioning, and automation testing documentation.
Ready to ensure excellence?
Apply now and let’s build quality together!
#J-18808-Ljbffr
Location Novato, United States
Work Mode Work From Office
Role Engineer, QA Validation
Pay Scale $85,363 – $106,716 (Dependent on Experience)
What You’ll Do
Review and approve user requirement specifications, automation functional requirement specifications, and software design documentation for automated facilities, utilities, and equipment.
Review and approve FATs, SATs, commissioning, and automation acceptance testing, qualification (IQ, OQ & PQ) protocols, validation discrepancy reports, and final report packages for facilities, utilities, and equipment to support implementation of new systems, changes, revalidation, and periodic review of existing systems.
Implement data integrity in a GMP environment.
Define and document the data life cycle for GMP systems.
Perform data integrity risk assessment and develop mitigation strategies to address risks.
What We’re Looking For
BS in a technical discipline (Engineering, physical, or biological sciences) or Equivalent experience.
Training in project management is preferred.
5+ years of experience in a GMP regulated environment (Biotech or equivalent) with exhibited knowledge or proficiency in engineering.
Experience in the review and approval of Validation and Qualification lifecycle documentation such as URS, IQ/OQ/PQ, commissioning, and automation testing documentation.
Ready to ensure excellence?
Apply now and let’s build quality together!
#J-18808-Ljbffr