Senior Computerized System Validation Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific is seeks a Senior Computerized System Validation Engineer to play a vital role in our digitalization and automation efforts. Our Tilburg site, a Center of Excellence since 1994, is dedicated to developing and commercially manufacturing gelatin-based drug delivery dosage forms (soft gels). Your leadership is essential for this important transition!

Job Responsibilities:

• Lead GxP CSV projects ensuring compliance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15.
• Validate GxP systems, aligning with industry practices and company policies, in manufacturing, laboratory, and facility systems.
• Develop documentation for computerized system validation, conduct validation processes, and document outcomes.
• Collaborate closely with manufacturing, IT, supply chain, and quality departments.
• Manage multiple projects, applying strong communication skills and making sound decisions in complex, time-sensitive situations.

Qualifications:

• 7-10 years of experience in the pharmaceutical industry, mainly in validation.
• Bachelor’s or university degree in IT, Science, or a related field, or equivalent experience.
• Demonstrated proficiency in computerized system validation, including cGMP automation/computerized systems.
• Background in project management with the ability to drive automation and digitization.
• Intense interest in acquiring knowledge and sharing insights on different facets of computerized system validation.

Personal Attributes:

• Integrity, Intensity, Innovation, and Involvement are essential characteristics.
• A proactive individual who thrives in a matrix organization and enjoys leading change.
• A “can do” mentality, eager to improve internal processes and contribute to a dynamic team.

Discover the happiness of making a significant impact in a world-class environment where your skills are valued and your growth is supported!