Thermo Fisher Scientific Process Engineer in Lenexa, Kansas
When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Responsible for resolving product and process problems and maintaining effective, efficient processes in the manufacturing of in vitro diagnostic and lab use culture media.
Location/Division Specific Information
Lenexa, KS / Microbiology Division
What will you do?
Review all non-conforming culture media for investigation, track results using Excel spreadsheets, and identify trends.
Lead investigations on product failures with RCCM, taskforces, quality control metrics
Identify and execute special projects that will bring cost savings through PPI programs. Drives practical process improvements in manufacturing through Six Sigma and Lean manufacturing techniques.
Develop and improve processing parameters (dry blending, mixing, cooling, solubility, freeze-drying, dispensing, thermal processing) for optimal process performance.
Perform literature reviews to resolve product performance
Implement engineering controls through SAP enhancements and equipment process controls through collaboration with Engineering and IT.
Resolves critical issues without affecting productivity. Utilization of good judgment on leveraging short-term effects versus long-term goals. Proficient in statistical and data analysis. Facilitate the acquisition of all of the data from DHR’s, logbooks, or new data acquisition equipment. Utilize Statistical Process Control, GR&R, Regression, and ANOVAs.
Drives special projects to drive business growth and profitability. Collaborate with R&D on new product implementation. Identify production needs and execute processes.
Resolve customer complaint issues through special projects and CAPA processes.
Review product formulations using batch records, technical manuals, and applicable publications in order to identify formulation discrepancies
Excellent collaborative skills, working with department supervisors and other departments using verbal and written communication to resolve product and process problems. Facilitate DoE discussions between MPD and Process Control. Utilize DoE software and build efficiency into testing. Facilitate Heightened Alert meetings for respective areas.
Initiate process variances to the identified nonconforming products in order to ensure identified problems are corrected immediately.
Initiate device change requests to products and standard operating procedures to resolve nonconformities based on the documented root cause analysis.
Report out regularly on Process Control in-process quality and customer quality notifications.
Utilize minimum inhibitory concentration (MIC) testing to develop antibiotic testing protocol for production.
Develops comprehensive antibiotic preparation and processing instructions for production.
Utilize preservative challenge (PCT) testing to develop new preservatives for business development.
Investigates antibiotic/microbiological response testing through RCCMs. Perform literature reviews to resolve product performance
Performs additional duties as needed.
How will you get here?
B.S./M.S. in Engineering, Microbiology, Chemistry, Biochemistry, or related field.
Advanced degree a plus.
Ability to manage and plan multiple projects
Analytical skills, good problem-solving technique and data analysis skills with Excel
Excellent communication skills, both written and verbal
Outgoing and collaborative in nature
Six Sigma or Lean manufacturing experience
Preferred to have 3-5 years technical experience that includes process engineering, process development, project management.
Preferred to have 3-5 years direct microbiology experience within the medical device or pharmaceutical industry
At Thermo Fisher Scientific, each one of our 80,000 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
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