Job Title: Validation Quality Engineer
Requisition ID: 41197BR
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
- To develop and execute the activities related to the validation of equipment, processes, packaging and/or systems used in the manufacture and testing of cGMP products.
- Contributes to the strategy and development of the site validation master plan.
- Solves problems in complicated situations using analytical and creative thinking skills.
- Evaluate and find mitigation for the potential risks that may be involved in a projected activity or undertaking.
- Impacts through delivery of results.
- Communicates internally to senior leaders and to diverse audiences.
- Completes assignments of diverse scope and complexity.
- Provides training and constructive input to team members.
- Supports complex, cross-functional quality investigations in a variety of subject matter areas (e.g. electrical, mechanical, chemistry and computer systems/software) to determine root cause and corrective action.
- Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
- Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects or quality improvement projects.
- May supervise the activities of lower-level personnel.
• Bachelor’s degree in Engineering or Science Discipline.
• 7 years’ experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
• Advanced knowledge of
- Validation in a FDA Regulated Environment
- Quality standards (e.g., 21 CFR Part 820, ISO 13485)
- Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)
- Computer Systems (e.g. TrackWise, AGILE, E1/SAP)
- Proficient in
- Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project)
- Technical writing
- Customer or regulatory audit
• Advanced knowledge of 21 CFR Part 11.
• Advanced knowledge of computer system validation
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.