Manufacturing Process Specialist

Manufacturing Process Specialist
RK5965
Onsite initially and then hybrid
Contract 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Reporting to Manufacturing Readiness Manager, this position is responsible for completing material supply investigations and supporting first line troubleshooting of the day-to-day activities within Operations



Duties:

• Support material supply investigations to ensure supply chain maintenance.
• Oversee and manage global records raised by the Digital Operations and Technical Services (DOTS) team assigned to Cork site.
• Generate change control documentation to record changes to the manufacturing process, materials, sites, etc.
• Evaluate and strategize shelf-life extensions for single-use consumables, optimizing material usage.
• Liaise with vendors and the wider members of the site to obtain relevant information for the completion of change controls.
• Investigating and resolving issues raised within the Manufacturing Department.
• Support Qualification activities for manufacturing single use consumables.
• Presenting to Change Control Board and raising of Change Controls for materials determined as suitable alternative for current materials.
• Prioritise and schedule activities to support business needs and to meet requirements of Master Production Schedule.
• Lead and Support investigation and resolution of problems on plant pertaining to single use material concerns.
• Participate in and lead Cross-Functional teams as necessary.
• Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.
• Provide training and support to colleagues where required.
• Work closely with QA to maintain product integrity within extended shelf-life parameters.
• Represent the Material Supply Optimisation Team and/or Operations on cross functional project teams.

• A relevant third level qualification in either Microbiology, Biochemistry, Biotechnology, Science or Engineering
• Manufacturing experience within a GMP regulated environment.
• Experience of SAP, electronic documentation system and/or other business systems.
• Lean/6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.