Astellas Pharma Computer Systems Validation (CSV) Engineer in United States
Computer Systems Validation Engineer
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.
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.
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 Sanford, North Carolina. 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.
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
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.
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
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
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.
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans