Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Position Summary: The Formulations Engineer II will be responsible for supporting the production line by assuring the manufacturing process meets or exceeds expected quality levels, as well as supporting manufacture of products for the Bulk Formulations team and completing associated cGMP documentation. Limited work with chemicals and biologicals to manufacture calibrators and controls for IVD use. Responsible for the implementation of product and process improvements. Contribute to the transfer of new products into Manufacturing from R&D. Participate in PPI initiatives.
· Developing, improving, implementing and validating new and/or improved manufacturing processes towards driving cost out of manufacturing processes
· Work closely with process validation and quality assurance team to develop processes, procedures, and specifications.
· Write, review, and present reports for Quality Systems, including: Variances, Nonconformances, and CAPA
· Work cross-functionally with R&D, Product Support, and Quality Systems for execution and implementation of validations and qualifications
· Collect, analyze, and report data to implement root cause countermeasures
· Maintain strict compliance with ISO13485, cGMP, QSR and other applicable Quality Management System standards
· Minimal participation in manufacture of calibrator and control products including chemical handling and clinical analyzer use.
· Keep department lead or manager updated on all issues.
· Perform other job duties as required.
· BS/BA in scientific/engineering discipline with 2-4 years of related experience and/or training preferred. AA degree with 4-6 years of related experience may be substituted.
· 2 years of Quality Assurance and/or Engineering experience within a regulated industry (e.g. medical device, pharmaceutical, biotechnology).
· Familiarity with Quality System Regulations.
· The ability to collect and analyze data and information, problem-solve, draw conclusions, and make recommendations.
· Preferred prior knowledge of statistical process controls
· Strong working knowledge of Microsoft Office required.
· Basic lab skills and knowledge of safety precautions.
· Experienced working with potentially hazardous chemicals and human source materials preferred.
· Must be able to lift 25 lbs occasionally.
· Ability to work independently with minimal guidance and as part of a team; establish priorities, manage multiple activities, and adjust to changing priorities in a dynamic work environment.
· Must be organized and detail-oriented to be able to prioritize their own and other’s work and meet business productivity metrics.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon. For more information, please visit www.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.