Senior Validation Engineer

Job overview

The Senior Validation Engineer role is onsite in Rochester, NY. Compensation is not specified. The role supports medical-device research and development validation activities and coordination with global teams and customers. The position exists to plan and execute validation work for equipment, process, and product transfers while maintaining alignment with applicable quality and regulatory standards. It contributes to project delivery through validation protocols, documentation, cross-functional problem-solving, and stakeholder coordination.

What you'll do

• Plan, lead, and coordinate project execution and validation activities
• support and execute validation plans and IQ, OQ, and PQ protocols for equipment, process, and product transfers
• author, review, and approve validation documentation
• collaborate with Quality, Production, and Engineering to resolve technical issues
• coordinate with customers, manufacturing plants, and offshore teams to support project continuity and timely delivery.

What we're looking for

Skills & competencies

senior validation engineer

rochester ny

katalyst healthcares & life sciences

medical devices

validation

research and development

iso 13485

iso 14971

iq oq pq

equipment transfer

process transfer

technical documentation

Work arrangement

• Weekend coverage required

Why this role

Medical-device industry experience is mandatory. Requires knowledge of ISO 13485 and ISO 14971 and hands-on IQ, OQ, and PQ experience; project manager or project lead experience is an added advantage.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.