Process Engineer

Essential Job Functions:

• Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Mentor and train other team members.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
• Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
• Participate and report to a cross-functional team to advance production activities.
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
• Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)
• Execute engineering studies, recipe development, and validation test cases.
• Work with vendors and suppliers to define requirements and understand functional specifications.
• Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.
• Work flexible hours for the coverage of the production facility.

Special Job Requirements:

• Knowledge of data management tools and RCM.
• Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or related scientific field.
• 3+ years’ experience in biopharmaceutical or other GXP regulated industry.

Additional Preferences:

• CMO/CDMO experience
• Technical and/or lean six sigma certifications