Senior Process Engineer

The Senior Process Engineer manages all technical aspects of assigned products and/or new processes in manufacturing. This includes preparing batch log records and cleaning log records, supporting production, conducting investigations, implementing corrective actions, and improving yields and cycle times.

Primary responsibilities will include but not be limited to:

• Works closely with Chemical Development, Production, and Quality Departments.
• Manages the transfer of assigned products and/or new processes into manufacturing.
• Trains production personnel on the execution of manufacturing processes.
• Provides input for and monitors actual manufacturing costs for assigned products.
• Trends manufacturing processes to ensure control and find areas for improvement.
• Identifies and implements cost reduction projects.
• Provides technical support to production for assigned products.
• Acts as manufacturing representative on capital projects involving assigned products.
• Conducts product/process failure investigations as appropriate.
• Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the clients Code of Conduct.
• Implements and adheres to all applicable SHE, DEA, and cGMP regulations.

Education: Bachelor or Master of Science degree in Chemical, Mechanical, Biochemical, or Petroleum Engineering from an accredited university is required.

Registration: Professional Engineering registration or CPIP certification is highly preferred.

Experience: This position requires a minimum of 10 years of relevant industrial experience in Pharma/Biotech Chemical Engineering. GMP/cGMP experience, Management of Change Process Implementations is required. Hands-on experience with tech transfers as well as in-depth knowledge of process engineering and cGMP regulations are required.

Knowledge, Skills, and Abilities Required:

• Must have excellent verbal and written communication skills.
• Must be able to work efficiently with people of all levels and cultures.
• Must be a team player.
• Must be highly organized and must be very conscientious and detail-oriented.
• Must be a self-starter and initiator.
• Must have good computer skills (word, spreadsheet, presentation).
• Must be able to manage several complex projects/issues simultaneously.
• Must be able to motivate and lead multi-disciplined, results-oriented teams.
• Must have good interpersonal skills with an ability to negotiate both internally and externally.
• Must be able to show determination and resilience.
• Must be able to execute sound commercial judgment.