Validation Engineer

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