Process Development Engineer

Process Development Engineer

Directly supports commercial manufacturing with real time evaluations and solutions. Conducts technical assessments, justifications and recommendations based upon risk with regards to manufacturing excursions and deviations. Defines and leads CAPAs to mitigate recurrence.

Leads associate teams in defining root cause analysis for technical investigations, deviations and critical complaints and offers direction to manufacturing investigation writers and the quality unit.

Supports alternate source API program and continuous improvement initiatives through operational excellence. Works with engineering, manufacturing and lean manufacturing groups to improve and develop new operating technologies and controls for oral solid dose processes.

Develops cGMP documentation and instructions to be in line with current practice and cGMPs. Works with Manufacturing personnel to address and alleviate issues before they occur.

Has basic understanding of technical concepts required for specified field. Uses that knowledge, creativity and company practices and priorities to obtain solutions to complex problems. Interfaces with senior management to provide and obtain information.

RESPONSIBILITIES:

• Performs root cause identification of product related investigations and defines CAPAs to mitigate and/or prevent recurrence.
• May provide and lead process improvements in support of lean manufacturing.
• Manages alternate source projects for Active Pharmaceutical Ingredients (API’s).
• Performs troubleshooting activities for daily support of manufacturing relating to process and equipment.
• May provide assistance/guidance to lower level scientists and technical staff.
• Documents findings, author’s reports and regulatory documents.

Education:

• BS and 5 years of related experience in Pharmaceutical industry or MS and 3 years of related experience in Pharmaceutical industry

Location: Nationwide