Validation Engineer

About the role

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.

Responsibilities

• Developing and executing qualification protocols
• Supporting SATs
• Performing cleaning validation and CSV activities across a variety of process equipment and manufacturing systems (e.g., filtration systems, filters, tanks, pumps, chromatography systems, bioreactors, and associated process equipment)
• Preparing and executing IQ/OQ/PQ documentation as applicable
• Supporting equipment readiness and startup
• Reviewing technical documentation
• Ensuring systems meet approved requirements and applicable GMP standards
• Working closely with engineering, quality, automation, and equipment vendors to resolve deficiencies, maintain compliance, and support the successful startup of manufacturing operations

Qualifications

• 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 (highly desirable)