Process Engineer

Siegfried•Pennsville, NJ

2d•Onsite

About The Position

The process engineer manages all technical aspects of assigned chemical processes in cGMP batch manufacturing of Active Pharmaceutical Ingredients and their intermediates. This includes designing or redesigning chemical processes to run in fixed, commercial-scale manufacturing equipment, preparing and/or revising master batch records, creating block flow and process flow diagrams, supporting production, conducting investigations, implementing corrective/preventative actions, and executing process improvements.

Requirements

Minimum of a bachelor's degree in chemical engineering and 0-5 years of hands-on experience in a pharmaceutical or fine chemical plant are required.
Must have excellent verbal and written communication skills.
Must have excellent computer skills (MS Office) and digital organization.
Must be very conscientious and detail-oriented.
Must be able to work efficiently with people of all levels and cultures.
Must be a team player.
Must be a self-starter and initiator.
Must be able to manage projects and prioritize appropriately.
Must have knowledge of organic chemistry.
Must have knowledge of equipment used in chemical manufacturing.

Nice To Haves

Understanding of process validation and/or Process Performance Qualification is preferred
Technical skill and/or experience with the following concepts is preferred: Batch chemistry, distillation, phase separation, crystallization, centrifugation, drying and milling

Responsibilities

Works closely with Chemical R&D, Production, Safety, Health, Environmental and Quality departments.
Manages the transfer of assigned products and/or new processes into commercial manufacturing.
Oversees pre-campaign readiness activities and conducts post-campaign reviews.
Interfaces directly with chemical operators for assigned products and maintains a presence in the plant during production of assigned products.
Trains chemical operators on the execution of Master Batch Records.
Provides input for and monitors actual manufacturing performance for assigned products.
Performs statistical data analysis of key performance indicators (KPIs) for each product process.
Reviews production campaign data and summarizes in Campaign Reports.
Identifies and implements process improvements benefitting cost, quality, yield, safety, and/or productivity.
Provides technical support and guidance to production for assigned products.
Acts as a subject matter expert on capital projects involving assigned products.
Facilitates product/process failure investigations to determine root causes and appropriate CAPAs.
Adheres to personal moral, ethical, legal, and behavioral conduct that follows the Siegfried Code of Conduct.
Adheres to all applicable Safety, Health and Environmental, DEA, and cGMP regulations.