Job Description:
Our client is seeking multiple Validation Engineers to support commissioning, qualification, and validation activities for a new manufacturing facility, including Process validation, cleaning validation and Computer system validation. Roles & Responsibilities:
The consultant will be responsible for developing and executing qualification protocols, supporting SATs, and performing cleaning validation and CSV activities across a variety of process equipment and manufacturing systems.
Equipment may include filtration systems, filters, tanks, pumps, chromatography systems, bioreactors, and associated process equipment. Responsibilities will include preparing and executing IQ/OQ/PQ documentation as applicable, supporting equipment readiness and startup, reviewing technical documentation, and ensuring systems meet approved requirements and applicable GMP standards.
The ideal candidate will have a strong background in equipment qualification and validation within pharmaceutical, biotechnology, or other regulated manufacturing environments.
Experience with cleaning validation, computerized system validation, risk assessments, requirements traceability, deviation resolution, and validation documentation is highly desirable.
The consultant will work closely with engineering, quality, automation, and equipment vendors to resolve deficiencies, maintain compliance, and support the successful startup of manufacturing operations.
Numbers & Facts
Location
Detroit, MI
Skills
Automationunmatched
Biotech and Pharmaceuticalunmatched
Chromatographic Systemsunmatched
Commissioning - Engineeringunmatched
Computer Systemsunmatched
Consultingunmatched
Documentationunmatched
Equipment Validationunmatched
GMP (Good Manufacturing Practices)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Operationsunmatched
Manufacturing Systemsunmatched
Process Manufacturingunmatched
Process Validationunmatched
Pumpsunmatched
Requirements Managementunmatched
Risk Analysisunmatched
Startupunmatched
System Start-Upunmatched
System Validationunmatched
Technical Writingunmatched
Traceabilityunmatched
Validation Documentationunmatched
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