Senior Engineer

Posted 16 November 2021
SalaryNegotiable
LocationCounty Mayo
Job type Temporary
DisciplineEngineering Careers
ReferenceBBBH495017_1637146999

Job description


Title: Senior Engineer
Location: Mayo
Summary:
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.

Responsibilities:

  • 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.

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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.