Process Engineer II

Discover Impactful Work

The process engineering team is responsible as the SMEs over the site's products and processes. The role is responsible for resolving product and process deviations and developing efficient processes in the manufacturing of in vitro diagnostic and lab use culture media.

Key Responsibilities

• Investigate non-conforming products and track results using Excel spreadsheets (Pivot Tables, PowerBI) and identify trends for RCA. Perform historical batch and literature reviews to resolve product performance (engineering, microbiology, chemistry)
• Drive special projects to drive business growth, cost savings, and profitability.
• Develop and improve processing methods (aseptic and non-aseptic dispensing, dry blending, mixing, cooling, solubility, freeze drying, dispensing, thermal processing, formulation)
• Author technical protocols and lead engineering studies.
• Operate industrial processing equipment (boiling tanks, blenders, dispensers, labellers, etc) to test processes, investigate issues, and build work instructions.
• Investigate process capability using Statistical DOE, Process Control, GR&R, Regression, and ANOVA (MiniTab).
• Author and lead changes within QMS; deviation investigations (planned and unplanned), CAPAs, customer complaints, SOPs, Batch Manufacturing Records, etc.
• Strong collaboration skills, working with department supervisors and other departments using verbal and written communication.

Minimum Requirements/Qualifications

• BS in Engineering, Microbiology, or other STEM degree required. Advanced degree a plus.
• Analytical 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
• Six Sigma or Lean Manufacturing
• Ability to Work on Manufacturing Floor
• 2+ years technical experience that includes process engineering, process development, project management.
• 1-5 years experience within the medical device or pharmaceutical industry
• Preferred to have 2+ years direct microbiology experience within the medical device or pharmaceutical industry

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