Title: Senior Engineer
Our client a leading company in the Medical Device field are looking to add a Senior Engineer to their team in Co. Mayo. This is an exciting opportunity to get involved in NPI & R&D Engineering.
- Coordinating & Managing R&D projects including New Product Introduction (NPI) and Product Transfers into the manufacturing plant.
- Providing regular project updates on project activities, milestones and status.
- Project scoping, costing & budget tracking.
- Managing projects liaising with local and global cross functional teams.
- Writing manufacturing validation protocols & reports for Feasibility trials, Process Evaluations, Registration Stability builds & Value Improvement Processes (VIPs)
- Tracking and ensuring completion of project milestones and compliance to project time-lines.
- Managing product, process and supplier changes which have a potential impact on products manufactured in Castlebar using the Design Change Control process.
- Coordinating document generation and review of Product File submissions to regulatory agencies. (FDA, HPRA, MHRA, EU RMS)
- Compliance to cGMP and Corporate Quality procedures.
Qualifications, Key Skills and Experience:
- B.Sc in Science (Engineering, Chemistry, Biology).
- Strong relevant Pharmaceutical/Healthcare experience.
- Demonstrating Strong project management and team leadership skills.
- Proven ability to work cross functionally as this role requires interaction with different functions within the plant.
- Analytical thinking using established tools for trouble shooting and investigation management.
- Ability to communicate (written and verbal) in a clear and concise manner.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.