Job Title: Engineer II, Deviation Investigator

Reports to: MSE Manager

When you’re part of our 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.

Location/Division Specific Information:

The Bedford/Chelmsford site manufactures consumables (Tropix Chemiluminescence, POP Genetics Analysis Polymers and POROS Chromatography Resins) for life sciences customers.

How will you make an impact

The Engineering Investigator will function as a key member of our Manufacturing Science & Engineering team. We are seeking an upbeat individual with strong communication, leadership, technical and operational skills to join our dynamic and fast paced team! The Engineer will work on driving investigations, implementing appropriate mitigation measures and making operational improvements!

What will you do?:

• Apply manufacturing / packaging process knowledge and investigational skills to identify and resolve critical manufacturing / packaging issues and product failures
• Conduct root cause analyses and implements solutions in a collaborative manner
• Drive continuous improvement in process operations
• Provide progress reports in weekly department meetings
• Support CAPA program requirements to assure timely closure.
• Demonstrate role model leadership of investigational practices
• Evaluate investigations and proposed corrective and preventative actions
• Coordinate meetings, leads conversations, and influences teams

How will you get here?

Education - Bachelor’s or Master’s degree in chemical engineering, or a related field

Experience - Minimum of 2-5 years of CAPA, investigations experience in a regulated industry and Good understanding of ISO 13485 requirements including CAPA, Risk Assessments, Deviation Investigations and Change Control processes

Knowledge, Skills, Abilities

• Strong oral, written, communication, presentation and interpersonal skills. and ability to work with numerous departments and levels of employees
• Knowledge of current Good Manufacturing Practices (cGMP)
• Understanding of statistical analysis techniques including process control
• Familiarity with Delta V and Six Sigma preferred
• Outstanding technical writing and problem solving skills required
• Exposure to Global Systems e.g. Trackwise, AGILE, E1/SAP

At Thermo Fisher Scientific, each one of our 70,000 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!

We are 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.