CSV Specialist

Job Description

About the Job

• Lead and execute validation projects for computerized and automation systems in compliance with GxP and other relevant regulatory standards.
• Develop, review, and maintain CSV standards, procedures, and guidance for lifecycle management.
• Author and review validation documentation, including validation plans, protocols, reports, traceability matrices, and risk assessments.
• Provide expert consultation and oversight to ensure compliance with regulatory requirements (e.g., GAMP 5, FDA 21 CFR Part 11, Annex 11).
• Collaborate with cross-functional teams (IT, Quality, Engineering, Operations) to plan and implement validation activities.
• Drive continuous improvement of validation processes, governance, and best practices.
• Make independent decisions related to validation strategy, execution, and deliverable approval.
• Support internal and external audits, ensuring inspection readiness and compliance alignment.

About You

• Academic background: engineering, life sciences, or related field
• 8–10 years of experience in Computer Systems Validation (CSV), Automation, or related quality and compliance roles within a regulated environment (pharmaceutical, biotech, or manufacturing preferred).
• Ability to lead projects from planning through execution and reporting, managing stakeholders and deliverables effectively.
• Prior experience in Rockwell Building Automation System (BAS) upgrades is highly preferred.
• Must be able to work independently, manage multiple priorities, and deliver results under minimal supervision.
• Demonstrated ability to make informed decisions and generate deliverables for system validation in a compliant and timely manner.
• Strong knowledge of regulatory frameworks (GxP, FDA 21 CFR Part 11, EU Annex 11) and validation lifecycle approaches (GAMP 5).
• Excellent analytical, problem-solving, and documentation skills.
• Strong communication and stakeholder management abilities across cross-functional and technical teams.

Why Join Us?

• Global Diversity: Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.
• Trust and Growth: With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.
• Continuous Learning: Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.
• Vibrant Culture: Enjoy a workplace where energy, fun, and camaraderie come together through regular afterworks, team-building events, and more.
• Meaningful Impact: Join us in making a difference through our CSR initiatives, including the WeCare Together program, and be part of something bigger.