IT CSV Engineer

Job Title: IT CSV Engineer

Location: Seattle, WA OR Redmond, WA

Reports to: Senior Manager/Group Leader, CSV

At Just‑Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward‑thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible.

We’re looking for a passionate and curious IT CSV Engineer to join our team. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. You’ll enjoy the freedom to ask hard questions, think outside the box, and find creative solutions that push us forward.

• Lead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative.
• Ensure adherence to client requirements, regulatory compliance, and project timelines.
• Collaborate with cross‑functional teams to execute complex CSV projects, including remediation and new system implementations.
• Develop validation strategies and author validation documents such as validation master plans, data migration plans, protocols, reports, and discrepancy resolutions.
• Manage and optimize validation testing processes, aligning risk‑based approaches with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices.
• Standardize and enhance CSV framework templates and procedures to drive continuous improvement initiatives.
• Support and oversee risk‑management activities, including risk‑based assessments and gap remediation efforts.
• Ensure compliance and maintain the validated state of all GxP systems.
• Manage external CSV consultants and oversee their contributions to CSV projects.
• Serve as a subject‑matter expert (SME) for Data Integrity, CSV lifecycle management, and compliance with global regulatory expectations.
• Own CSV‑related deviations and CAPAs, managing remediation efforts related to CSV and Data Integrity.
• Partner with IT to establish backup/restore protocols, disaster recovery strategies, adherence to data retention schedules, and infrastructure qualification requirements.
• Assist business and technical owners in developing requirements and specifications for computerized systems used in GxP operations.
• Oversee the authoring and execution of IQ, OQ, and PQ test scripts.

• Strong experience with GxP computer systems validation and compliance.
• In‑depth knowledge of GxP regulations and CSV/CSA principles, including but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
• Experience with Quality Risk Management (ICH Q9) and its application in CSV.
• 5+ years of experience in GxP CSV roles.
• Thorough understanding of validation/qualification concepts within pharmaceutical quality systems.
• Strong technical writing skills for validation documentation and compliance reporting.
• Excellent communication skills (both oral and written) with the ability to effectively interact across organizational levels and functions.

• Growth Opportunities:
  Continuous learning and development through professional courses, mentorship, and new projects.
• Inclusive Culture: A diverse and inclusive environment where every voice is valued.
• Innovative Projects:
  The chance to work on groundbreaking initiatives with cutting‑edge technology.

Base pay range: $115,000 to $135,000. Additional total rewards include discretionary annual bonus, comprehensive benefits (Medical, Dental, Vision), short‑term and long‑term disability, company‑paid basic life insurance, 401(k) company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.