KC
Validation Engineer
External job listingat Katalyst CRO
Validation Engineer in Detroit, MI. Supports CQV activities for a new manufacturing facility. Send your resume or connect with us.
External source - not verified2 weeks agoOpen until: Jan 11, 2027
Salary
Not provided
Location
Detroit, United States
Employment type
Full time
Workplace
Not provided
Validation Engineer
Detroit, United States
Job description
About the role
Support commissioning, qualification, and validation (CQV) activities for a new manufacturing facility.
Tasks
- Develop and execute qualification protocols and support Site Acceptance Testing (#SAT).
- Perform Installation Qualification (#IQ), Operational Qualification (#OQ), and Performance Qualification (#PQ) activities as applicable.
- Support process validation, cleaning validation, and computer system validation (#CSV).
- Qualify process equipment, including filtration systems, filters, tanks, pumps, chromatography systems, and bioreactors.
- Support equipment readiness, startup activities, and manufacturing facility commissioning.
Requirements
- Strong experience in equipment qualification and validation within pharmaceutical, biotechnology, or other regulated manufacturing environments.
- Hands-on experience developing and executing #IQ/OQ/PQ protocols.
- Knowledge of commissioning, qualification, and validation (#CQV) activities.
- Experience with cleaning validation, process validation, and/or computer system validation (#CSV).
- Understanding of #GMP requirements, validation documentation, risk assessments, and requirements traceability.
- Preferred: Experience supporting new manufacturing facility startup and equipment qualification.
- Preferred: Familiarity with filtration systems, tanks, pumps, chromatography systems, and bioreactors.
- Preferred: Experience working with Engineering, Quality Assurance, Automation, and equipment vendors.
How to apply
- Connect with us or send your resume.
Location
- Detroit, MI