Description:
Excellent opportunity to join a leading Medical Device company based in Cork to work on a New Pharma Product Development.
The successful candidate will work with cross-functional teams to lead process development of complex technologies on new products and ensure efficient and effective transfer of product into production. This role will focus on process scale up of novel chemistry based products.
Key Responsibilities
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
- Identifies and introduces manufacturing processes suitable for chemical processing including powder handling, formulation, blending, drying, milling and packaging technologies.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Plans, organizes, and conducts all aspects of technical reviews.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
- Writes and reviews validation protocols and reports applicable to new processes.
- Oversees development builds associated with the project using special work requests.
- Develops qualified production lines.
- Provides Design for Manufacturability (DFM) input to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
- May serve as a core team member or extended team member on new product projects.
Requirements
- Level 8 Degree Qualified in a relevant discipline
- 1-3 years experience working in Medical Devices/Pharma desirable.
- Excellent problem solving skills
- Fluent English
- Excellent communication skills