Process Engineer III / Engineer III

Duties

• Performs all functions associated with process transfer and process support to develop process understanding, perform gap analysis / FMEA, generate process models, author / review process descriptions and batch records, author / review planned deviations and change controls, perform process monitoring including manufacturing data summary and analysis, data presentation, author campaign summary reports, perform activities for lot release including assess deviations and process changes.
• Provide guidance on process transfer and support activities to junior members of the team.
• Assess all major deviations including those that impact product quality. Identify potential root causes using a systematic approach. Use variety of problem-solving tools including Fishbone. Identify potential solutions.
• Perform and understand all types of complex data analysis. Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates.
• Assess change controls for impact of any change to the process, equipment and procedures that can affect process performance and product quality.
• Support documentation preparation for regulatory purposes.
• Represent Manufacturing Science and Technology (MSAT) on project teams and interfaces with customer technical and quality representatives.
• Represent MSAT on internal teams including deviation and run daily management system meetings.
• Participate in Customer and Regulatory Audits.
• Follow all training and policy guidelines established for the facility along with all cGMP requirements.
• Ensure employee training profile is always up to date by regular monitoring of training lists including Compliance Wire, SAP Learning Portal and completing all training in a timely fashion.

Minimum Requirements

• Requires a Master’s degree, or foreign equivalent degree, in Chemical Engineering, Biological Sciences or Biomedical Engineering and Three (3) years of experience in the job offered, or Three (3) years of experience in a related occupation using variety of problem-solving tools including Fishbone; identifying potential solutions; performing and understanding all types of complex data analysis; representing Manufacturing Science and Technology (MSAT) on project teams and interfaces with customer technical and quality representatives; following all training and policy guidelines established for the facility along with all cGMP requirements; ensuring employee training profile is always up to date by regular monitoring of training lists including Compliance Wire, SAP Learning Portal and completing all training in a timely fashion.