Lead Process Engineer

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.

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:

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.

EDUCATION AND EXPERIENCE:

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.

OTHER REQUIREMENTS:

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