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.

LOCATION/DIVISION SPECIFIC INFORMATION:

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

HOW WILL YOU MAKE AN IMPACT?

The Engineering Investigator will function as a key member of the Manufacturing Science & Engineering team. We are seeking an energetic individual with strong communication, leadership, technical and operational skills to join our dynamic and fast paced team. The Engineering Investigator will work on driving root cause analysis and identification of appropriate corrective actions.

RESPONSIBILITIES

• Perform and document and process investigations regarding plant issues and critical product failures

• Able to handle challenging, in-depth investigations utilizing investigational tools

• Conduct root cause analysis and implement solutions in collaboration with the team

• Investigate, write and close out root cause investigations/CAPAs

• Evaluate corrective actions, identify and implement preventive actions to eliminate the potential for non-conformities to occur.

• Report progress in the weekly department meetings

• Support CAPA program requirements to assure timely closure. Promote consistency in investigation practices.

• Ability to coordinate and facilitate meetings, lead conversations, and influence teams

HOW WILL YOU GET HERE?

EDUCATION

• Bachelor’s Degree or higher in technical / scientific discipline.
• Minimum educational requirement: Bachelor's Degree and high school diploma/GED

EXPERIENCE

• Minimum of 2 years of CAPA, investigations experience in a regulated industry

• Good understanding of ISO 13485 requirements including CAPA, Risk Assessments, Deviation Investigation and Change Control process.

KNOWLEDGE, SKILLS, ABILITIES

• Strong oral, written, communication, presentation and interpersonal skills.

• Ability to work with numerous departments and levels of employees.

• Knowledge of current Good Manufacturing Practices (cGMP)

• Understanding of statistical tools and statistical process control

• Delta V and Six Sigma preferred

• Superior technical writing and problem solving skills required

• Global Systems e.g. Trackwise, AGILE, E1/SAP

At Thermo Fisher Scientific, each one of our 75,000 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

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.