Senior Computer Systems Validation Engineer

4 weeks ago

College Station, Texas, United States Fujifilm Full time
Job Summary

The Senior Computer Systems Validation Engineer will be responsible for overseeing the validation of all GxP-regulated computerized systems at Fujifilm Diosynth Biotechnologies. This includes ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. The ideal candidate will have a strong understanding of engineering principles and computerized systems validation, as well as excellent written and oral communication skills.

Key Responsibilities:

  • Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports.
  • Plan and organize validation activities amongst cross-functional groups, providing status updates for validation activities related to day-to-day operations or project work.
  • Review all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback and ensuring adherence to associated Standard Operating Procedures (SOPs).
  • Create, review, and update SOPs, forms, templates, documentation, and files.
  • Support regulatory and client audits as CSV subject matter expert.

Requirements:

  • Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 3 years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
  • Bachelor of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 5 years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
  • Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 7 years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Knowledge of DeltaV automation platform preferred.
  • Working knowledge of engineering principles.
  • Working knowledge and expertise in computerized systems validation.
  • Computer System Validation experience with DCS, SCADA, and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
  • Thorough knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements, and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, PowerPoint).
  • Ability to work with minimal supervision.
  • Desire to work in a fast-paced, state-of-the-art, alternately research and customized manufacturing facility.
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged standing, some bending, stooping, and stretching. The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds is also required. Working on ladders is also a requirement.

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