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Astellas Pharma Senior Computer Systems Validation Engineer in South San Francisco, California

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

As part of the Astellas Gene Therapies (AGT) Enterprise Engineering & Facilities team, the Computer System Validation (CSV) Engineer will deliver validation support for our process automation and QC laboratory systems, supporting our South San Francisco and Sanford, North Carolina locations. The position would require onsite presence in either South San Francisco. This role will report to the Director, Information Technology and Automation and requires advanced knowledge of computer system validation and a strong focus on customer service. This role will include some business analysis skills, mainly the ability to help customers define user requirements and identify technical solutions to address those requirements. The CSV Engineer must be a team player that understands the importance of collaboration, while also able to take direction and drive the resolution of issues to completion with minimal supervision. Some travel will be required.

Primary Responsibilities

  • Responsible for all validation services supporting qualification activities associated with Computer System Validation

  • Accountable for documentation, which may include, but is not limited to:

  • Generate protocols, summary reports, and protocol exceptions

  • User Requirements

  • Functional and/or technical specifications

  • Process flow diagrams

  • Training documentation and/or work instructions

  • Schedule and execute all qualification activities

  • Responsible for qualification data collection and analysis against acceptance criteria

  • Provide documentation updates (SOPs, Forms, etc.)

  • Provides consultation to customers regarding enhancement/improvement of current solutions and implementation of new solutions -- both systems and processes.

  • Facilitates and/or supports customers in UAT planning and execution.

  • Participates in and advises roadmap discussions, key member of vendor assessment teams.

About you

Must Have/Required

  • BS/BA degree in engineering, information systems or equivalent with a combination of education/work experience

  • 5+ years of Computer System Validation experience

  • Strong knowledge of Automated Systems Qualification

  • Adequate understanding of cGxP guidelines

  • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.

  • Experience in the life science and/or pharmaceutical industry

  • Experience with validated environments, change management, and discrepancy reporting

  • Excellent written and verbal communication skills; ability to quickly produce clearly written, well-organized documentation

  • Strong attention to detail

  • Proven skills in relationship building, customer-focus, decision-making, and problem solving

  • Demonstrated ability to quickly learn the business in unfamiliar areas

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Experience with systems including MFCS/win, DeltaV, UNICORN, OSI PI, Schneider BMS, Vaisala EMS, Rockwell FactoryTalk, RF Smart, Labware, Empower, and PIMS a plus

  • Experience supporting users and applications in both lab and manufacturing environments.

  • Experience with systems and application used in GxP manufacturing facilities.

  • Experience in a small company and high growth, fast-paced environment.


  • 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

  • Referral bonus program


Category Gene Therapy Research & Technical Operations

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

EOE including Disability/Protected Veterans