Engineer II, Validation - Computerised Systems Validation Specialist

at  Thermo Fisher Scientific

ABOUT THE JOB

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 75,000 employees globally. Are you ready to make a significant impact in the world of science and technology as a Computerised Systems Validation Specialist? We are looking for a highly skilled and diligent CSV Specialist to join our team. Together we will contribute to important work, like helping our customers accelerate life sciences research, solve complex analytical challenges, and improve patient diagnostics. We are committed to supporting your career goals and providing an innovative and dynamic work environment.

POSITION SUMMARY:

As a CSV specialist you will utilise your expert knowledge of software validation to drive the progression of validation studies and ensure compliance with regulatory requirements. The candidate will work closely with teams across our site, focusing on software projects such as analyser platform regression testing, ERP/eQMS patches, MES implementation, and spreadsheet validation.

PREFERRED SKILLS/EXPERIENCE:

The Validation team supports all pillars of validation within the business to drive process improvements across manufacturing. We encourage candidates who thrive in a multi-disciplinary, highly technical environment where personal development and collaboration are keys to success. Sound decision-making skills in time-sensitive and sophisticated situations, with a considered assessment of risk, are crucial. Demonstrated experience of handling numerous projects and priorities is a must.

QUALIFICATIONS:

• Bachelor’s degree in Computer Science, Engineering, or a related field. A Master’s degree is preferred.
• Proven experience in CSV in a regulated industry such as pharmaceuticals, medical devices, or biotechnology.
• Solid understanding of regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Preferred: ISO 13485, FDA Part 820
• Excellent attention to detail and ability to work independently with minimal direction.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
  Apply today! http://jobs.thermofisher.co

• Develop and maintain documentation, including plans, protocols and reports for qualification activities (e.g., IQ, OQ, PQ).
• Collaborate with multi-functional teams, including manufacturing, IT, Quality Assurance, and Regulatory Affairs, to ensure appropriate validation of software systems.
• Perform risk assessments and develop risk mitigation strategies to ensure compliance and data integrity.
• Provide technical expertise and guidance on CSV to internal customers.
• Stay up to date with industry trends and regulatory requirements related to CSV.
• Participate in internal and external audits, where needed, and assist in addressing any findings.