Process Development Engineer II
CREGG are currently hiring a Process Development Engineer II to work onsite with a leading medical device multinational client in Cork. Call Stephen Coen 0861030418 Email: stephencoen@cregg.ie
Develops, prepares and tests materials, prototypes and finished products in support of prototype drug product screening, process optimisation and scale-up.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
- Applies technical chemistry knowledge to innovate, design, develop and characterise processes, procedures, tooling and/or automation.
- Conducts wet chemistry techniques towards synthesis of organic, inorganic, or polymeric substrates
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Prepares and presents technical data and recommendations at technical reviews.
- Writes validation protocols and reports applicable to new processes.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
- 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 may train manufacturing personnel when required as part of a validation.
- May serve as core team member or extended team member on new product projects.
