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Senior Process Development Engineer

2 weeks ago

Nenagh, County Tipperary, Ireland beBee Careers Full time

Salary: Competitive package based on qualifications and experience.

Job Description

This is a fantastic opportunity for a Senior Process Engineer to join our growing Commercialisation, Development and Supply team. The role provides exciting and challenging opportunities to work on multiple API projects, ranging from manufacturing support activities to late-stage clinical product development and scale-up, new product introductions and technology transfers across existing and new facilities.

Key Responsibilities:
  • Lead engineer on new product introductions and/or technical transfers to and from the site, including new technologies.
  • Co-develop new SM API products with Research and Development partners globally.
  • Direct day-to-day project development plans.

The successful candidate will provide knowledge and subject matter expertise on API processing unit operations and scale up to colleagues in Quality, Supply Chain and Manufacturing Operations. This includes evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies.