Process Engineer II
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Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Loud Noises (Equipment/Machinery) Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) WarehouseJob Description
The Microbiology Division provides solutions and workflow for clinical pharmaceutical and food testing environments. The markets we serve include food manufacturers and labs clinical and healthcare pharma and biotech. We manufacture culture media and other microbiological diagnostic products serving customers in the pharmaceutical food and clinical laboratories.
Discover Impactful Work:
The process engineering team is responsible as the SMEs over sites 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
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Apply today!
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
