Validation Engineer

Astellas Pharma-posted 2 months ago

Full-time • Mid Level

Hybrid • San Francisco, CA

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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.

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/CO₂ 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.
Lead Data Integrity Risk Assessments for new and existing systems, define mitigations, track actions to closure, and maintain a cross-site DI risk register.
Establish and run periodic reviews, including audit trail review strategy and execution, backup and restore verification, security and access recertification, time synchronization checks, data retention and archival verification, and disaster recovery elements aligned to ALCOA+ plus principles.
Define data flows and lifecycle maps for key applications and studies to ensure traceable, attributable, legible, contemporaneous, original, and accurate records.
Align validation and DI deliverables to enable product characterization work packages that support regulatory submissions.
Prepare transfer packets that demonstrate fitness for intended use and continuity of controls for tech transfer to downstream GxP organizations.
Plan, execute, and periodically review controls for platforms such as LIMS, ELN, CMMS, EMS, data systems and related lab or enterprise applications used by CGT Research.
Partner with IS and DigitalX on account and role design, backup and recovery, business continuity, and incident response linkages for these platforms.
Author and maintain SOPs, work instructions, validation plan templates, DIRA tools, periodic review checklists, and report templates.
Deliver role-appropriate training and coach scientists and engineers on validation and data integrity practices, including good documentation practices.
Define scopes of work, guide tasking, review deliverables, and ensure on-time, right-first-time outputs from contractors and suppliers.
Oversight of local contractors or vendors providing equipment qualification
Lead or support investigations related to validation or data integrity gaps, assess impact to studies and submissions, and drive effective CAPAs.
Document root cause, corrective and preventive actions, and ensure timely closure with supporting evidence.
Maintain dashboards for CSV status, DIRA actions, and periodic review health, and present program status in reviews.
Support internal audits and GLP inspections, prepare evidence, and complete commitments.

BS in Engineering, Information Systems, Computer Science, Life Sciences, or related field, or equivalent combination of education and experience.
8+ years of Computerized Systems Validation experience with hands-on authorship and execution of URS, specifications, risk assessments, IQ, OQ, UAT, traceability, and summary reports.
Demonstrated experience running DIRAs and periodic reviews, including audit trail review, access recertification, backup and restore verification, and change control linkages.
Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GLP expectations for computerized systems, and research best practices for submission-supporting data.
Excellent technical writing and documentation skills with the ability to produce clear, well-structured protocols and reports quickly.
Strong collaboration and project management skills across multi-site environments, including influencing without direct authority.
Models Astellas values, operates with transparency, and builds trust.

Experience in gene therapy, biologics, or advanced therapy research organizations and GLP laboratories.
Familiarity with lab instrumentation connectivity, interface testing, and integration validation between lab and enterprise systems.
Prior responsibility for contractor oversight and multi-workstream validation delivery.
Experience preparing validation and data integrity evidence for audits or inspections.

Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program

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