Job Title: Product Development Engineer
Roles and Responsibilities:
As a Project Leader in the Product Development department, you will be responsible for management of product focused projects.
The Product Development Project Lead will have responsibility for management of product specific projects including:
- Coordinating and 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 and budget tracking.
- Managing projects liaising with local and global cross functional teams.
- Writing manufacturing validation protocols and reports for Feasibility trials, Process Evaluations, Registration Stability builds and 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 industries (FDA, HPRA, MHRA, EU RMS)
- Compliance to cGMP and Corporate Quality procedures.
Qualifications 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 investigating 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.