Product Development Engineer
Dolmen Engineering currently have a requirement for a Product development Engineer for our client site in Castlebar Co. Mayo. As a Project Leader in the Product Development department, you will be responsible for management of product focussed projects.
Essential Duties and Responsibilities:
The Product Development Project Lead will have responsibility for management of product specific projects including:
•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 timelines.
• 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.