IT CSV Engineer

Job Title: IT CSV Engineer

Location: Seattle WA OR Redmond WA

Reports to: Senior Manager/Group Leader CSV

About Us:

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 whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper#BeCureious with us and see where your curiosity can take you!

The Role:

Were looking for a passionate and curious IT CSV Engineer to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As an IT CSV Engineer at Just-Evotec youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

What Youll Do:

• 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 Computer System Validation (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 ensuring risk-based validation approaches align 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.

Who You Are:

• 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.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!

The base pay range for this position at commencement of employment is expected to be $115000 to $135000; Base salary offered may vary depending on individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k 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.