IT CSV Engineer

The Role

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

What You'll 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.
• 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.

Benefits

• Base pay range: $115,000 to $135,000 at commencement of employment.
• 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 holiday, wellness and transportation benefits.