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!