Process Engineer II

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description Company Information About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD. For more information, please visit  www.thermofisher.com Job Description Job Description Job Title: Process Engineer Reports To: Manager, Process Engineering Group/Division: SDG/MBD Career Band: 5 Job Track: Professional Position Location: Lenexa Number of Direct Reports: 0 Day/Shift (if applicable): Day FLSA Status (Exempt/Non-Exempt): Exempt Position Summary: The process engineering role is responsible as the subject matter expert over site’s products and processes. The role is responsible for resolving product and process deviations and maintaining efficient processes in the manufacturing of in vitro diagnostic and lab use culture media.

Review and investigate all non-conforming culture media, track results using Excel spreadsheets (Pivot Tables, PowerBI) and identify trends for RCA. Drives special projects to drive business growth, cost savings, and profitability. Perform historical product batch and literature reviews to resolve product performance (engineering, microbiology, chemistry, equipment) Drives practical process improvements in manufacturing through Six Sigma and Lean manufacturing techniques. Develop and improve processing methods (aseptic and non aseptic dispensing, dry blending, mixing, cooling, solubility, freeze drying, dispensing, thermal processing, formulation) Implement engineering controls for equipment. Resolves critical issues without affecting productivity. Utilization of good judgment on short term versus long term goals. Author protocols to complete engineering studies on products and processes. Work with industrial processing equipment (boiling tanks, blenders, dispensers, labellers, etc) to test processes, investigate issues, and build work instructions. Proficient in statistical and data analysis (ex. MiniTab). Use Statistical DoE, Process Control, GR&R, Regression, and ANOVAs to determine process capability. Author and lead investigations within QMS; deviation investigations (planned and unplanned), CAPAs, and customer complaints. Strong collaboration skills, working with department supervisors and other departments using verbal and written communication. Update documentation such as batch records or SOPs, as required. Performs additional duties as needed. Minimum Requirements/Qualifications: Possess a BS in Engineering (preferred) or other STEM degree. Analytical skills, good problem-solving technique and data analysis skills with Excel and statistical software Technical Writing Experience with ISO 9001 and ISO 13485 Excellent communication skills, both written and verbal Ability to handle and plan multiple projects Outgoing and collaborative in nature Detail Oriented