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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
- Detail Oriented
- 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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