Senior System Administrator (SAP expert)Purpose & Scope 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 SAP. The position ensures ongoing data integrity and 21 CFR Part 11 compliance across manufacturing and laboratory systems.
Role and 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.
Required Qualifications - 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 SAP 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
Preferred Qualifications - Experience in a fast-paced, high-growth biopharma or gene therapy environment.
- Experience with additional digital platforms (BMRAM, Labware LIMS, Tempo).
- Hands-on experience with instrument integration or data capture workflows.
Location and Working Environment- This is an on-site role working in a cGMP regulated manufacturing facility.
- On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
Salary Range$94,570 - $135,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
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
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