Engineer III, Computer Systems Validation

Work Schedule

• Environmental Conditions
• Job Description
• As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges.
• Description:
• Join our validation engineering team as a Validation Engineer III (Computer Systems Validation – CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.
• In this role, you will lead and execute validation activities with a strong focus on automation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements.
• You will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits. This role requires a high level of independence, technical expertise, and the ability to lead complex validation efforts.
• A Day in the Role:
• Lead validation activities for equipment, processes, utilities, and computer systems, with emphasis on CSV
• Evaluate and support change management for existing manufacturing systems and automation platforms
• Author, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans
• Perform and lead risk assessments, gap analyses, and validation assessments