Lead Process Engineer

SUMMARY

The incumbent 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.

• 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 Code of Conduct.
• Implements and adheres to all applicable SHE, DEA, and cGMP regulations.

• An advanced degree in Chemical Engineering and/or 10+ years of hands‑on experience in a pharmaceutical batch plant are required.
• Hands‑on experience with tech transfers as well as in-depth knowledge of process engineering and cGMP regulations, are required.
• Must have excellent role model/leadership capabilities.

• 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‑orientated 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.