Validation Engineer

Katalyst CRO; Detroit (MI); On-site; USD 95,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking multiple Validation Engineers to support commissioning, qualification, and validation activities for a new manufacturing facility. The role covers process validation, cleaning validation, and computerized system validation across diverse process equipment and systems.

The ideal candidate has strong qualification/validation background in pharma/biotech or other regulated environments, with experience in cleaning validation, risk assessments, and validation documentation.

Qualifications

• Experience in equipment qualification and validation within pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience with cleaning validation and computerized system validation.
• Experience with risk assessments, requirements traceability, deviation resolution, and validation documentation.

Responsibilities

• Develop and execute qualification protocols, support SATs, and perform cleaning validation and CSV activities across process equipment and manufacturing systems.
• Prepare and execute IQ/OQ/PQ documentation, support equipment readiness and startup, review technical documentation, and ensure systems meet GMP standards.
• Collaborate with engineering, quality, automation and equipment vendors to resolve deficiencies and support startup.

Skills

Equipment qualification

Validation

GMP knowledge

Risk assessments

Requirements traceability

Deviation resolution

Validation documentation

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.