Quality
Validation Engineer / Validation SME for our Controlled Temperature Units
Opportunity summary
Employment type: Full time. Requisition: R0012465. Start: 2026-09-04. Country: [object Object].
FUJIFILM Biotechnologies (FLBD) is seeking an experienced Validation Engineer / Validation Subject Matter Expert (SME) to drive validation activities related to Controlled Temperature Units (CTUs) including Refrigerator, Freezer, Cold room, Warehouse and Incubator.
This is a highly visible role requiring deep technical expertise, strong regulatory knowledge, and the ability to provide strategic direction for qualification and validation activities for CTUs.
The successful candidate will act as validation SME within the area and play a key role in ensuring compliance with global regulatory requirements while supporting ongoing operations, expansion projects, and inspection readiness.
Main Responsibilities Serve as Validation SME for one type of CTU (Refrigerators) Technical ownership of the validation program for CTUs Act as validation SME during customer audits & regulatory agency inspections. Drive inspection readiness activities and support remediation of audit observations and regulatory commitments Decision-making authority on validation strategy and risk-based ap1 …
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