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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/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.

Data Integrity Program

+ 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.

Lab and equipment platforms

+ 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.

Procedures, Templates, and Training

+ 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.

Contractor and Vendor Management

+ 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

Issue Management, Metrics, and Audit Support

+ 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.

Required Qualifications

+ 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.

Preferred Qualifications

+ 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.

Working Conditions:

+ Hybrid office and lab setting with routine interaction with computerized systems and occasional time in labs and equipment rooms. Locations could be in South San Francisco, CA, Westborough, MA, and Seattle, WA with travel up to 10 percent.

**Salary Range** : $107,100-153,000 (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ 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

_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._

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Category Facilities, Engineering and Logistics

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans