Validation Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at  www.astellas.com .

The Role

As part of the Research Compliance team, the Validation Engineer plans and executes risk-based qualification and computerized systems validation activities in cell and gene therapy research environments and advances data integrity improvement programs for systems and equipment platforms. The role manages contractor resources, partners with cross functional research and enterprise supportive functions and drives deliverables to completion with minimal supervision.

Responsibilities :

CSV and Qualification Lifecycle

• Plan and execute risk-based CSV for research computerized systems and instrument-connected software, including URS, functional and design specifications, configuration records, risk assessments, traceability matrices, IQ, OQ, and validation summary reports.
• Qualify non-computerized equipment (e.g., freezers, refrigerators, incubators, TCUs, chromatography columns) using a fit-for-purpose, risk-based approach, including URS, risk assessment, calibration / verification, temperature / CO ₂ mapping where applicable, functional and alarm checks, acceptance criteria, maintenance plans, periodic requalification, and documented change control.
• Validate data migrations, interfaces, and integrations between lab and enterprise systems.
• Maintain lifecycle controls, including change control, deviation handling, CAPA linkage, and validated state documentation.
• Coordinate and document vendor assessments, service qualifications, and supplier deliverables used as validation inputs.
• Ensure validated-state documentation, vendor service records, and calibration certificates are current and audit-ready.
• Initiate, assess, execute, and close change controls related to equipment and systems tracked in BMRAM.
• Ensure changes are documented, assessed for impact, and properly linked to validation deliverables.

Data Integrity Program

Lab and equipment platforms

Procedures, Templates, and Training

Contractor and Vendor Management

Issue Management, Metrics, and Audit Support