Astellas Pharma · 1 day ago
Validation Engineer
South San Francisco, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$107K/yr - $168K/yr
8+ years expAstellas Pharma Inc. is a pharmaceutical company dedicated to developing innovative therapies for patients. The Validation Engineer will be responsible for planning and executing qualification and validation activities in cell and gene therapy research environments, focusing on data integrity and managing contractor resources.
BiotechnologyHealth CareMedical
Responsibilities
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
Qualification
Required
BS in Engineering, Information Systems, Computer Science, Life Sciences
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
In lieu of BS degree, Associates Degree in Engineering, Info Systems, Computer Science, Life Sciences, with 10+ years of industry experience
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
Preferred
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
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Company fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
2025-12-18
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