System Administrator

Astellas Pharma • Westborough, MA

10h • Onsite

About The Position

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 [http://www.astellas.com].

Astellas is announcing a System Administrator opportunity at their Astellas
Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The System Administrator supports the implementation, operation, and maintenance
of digital and computerized systems within a cGMP manufacturing environment.
Acting as the primary link between Operations and IT, this role manages system
configuration, user access, and master data for core applications such as LIMS
and EBR. The position ensures ongoing data integrity and 21 CFR Part 11
compliance across manufacturing and laboratory systems.

Requirements

• B.S. in biological sciences, chemistry, or related field with 5+ years (or M.S. with 3+ years) experience managing analytical or manufacturing computerized systems.
• Strong knowledge of GMP, 21 CFR Part 11, and data integrity principles.
• Experience with LIMS and/or EBR system administration and validation.
• Familiarity with Windows environments, networks, and laboratory system integration.
• Excellent technical writing, communication, and troubleshooting skills.
• Demonstrated ability to work collaboratively and manage multiple priorities in a regulated setting

Nice To Haves

• Experience in a fast-paced, high-growth biopharma or gene therapy environment.
• Experience with additional digital platforms (SAP, BMRAM, Labware LIMS, Tempo).
• Hands-on experience with instrument integration or data capture workflows.

Responsibilities

• Administer and maintain site computerized systems, including configuration, access control, and master data management.
• Serve as first-line support for user issues and coordinate system troubleshooting, change control, and periodic maintenance.
• Develop and maintain documentation including URS, configuration guides, validation protocols, SOPs, and training materials.
• Partner with IT, QA, and system vendors to manage system qualification (IQ/OQ/PQ), updates, and change management activities.
• Ensure systems operate in compliance with cGMP and data integrity standards; support internal/external audits and inspections.
• Support onboarding and training for system users and monitor compliance metrics for continuous improvement. Develop and maintain validation templates, SOPs, and training programs.

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-paid fleet vehicle for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level