Manufacturing Process Specialist, Biologics (12M, Cork)

Manufacturing Process Specialist - Biologics, Cork

Contract: 12 month initial term, 5 days onsite initially, transitioning to hybrid (3 days per week). Reports to Manufacturing Readiness Manager.

Note: No sponsorship is provided for this role; applicants must already have Irish/EU citizenship or the relevant stamp/visa.

Responsibilities

• Support material supply investigations to ensure supply chain maintenance.
• Oversee and manage global records raised by the Digital Operations and Technical Services (DOTS) team.
• Generate change control documentation to record changes to the manufacturing process, materials, sites, etc.
• Evaluate and strategise shelf life extensions for single use consumables, optimising material usage.
• Liaise with vendors and wider members of the Cork Bio site to obtain relevant information for change controls.
• Investigate and resolve issues raised within the Manufacturing Department.
• Support qualification activities for manufacturing single use consumables.
• Present to the Change Control Board and raise change controls for materials determined suitable as alternatives to current materials.
• Complete assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.

Qualifications & Experience

• Relevant third level qualification in Microbiology, Biochemistry, Biotechnology, Science or Engineering.
• Experience in a GMP regulated manufacturing environment. (Desirable)
• Postgraduate qualification. (Desirable)
• Experience with Microsoft Word, Excel and Outlook.
• Experience with SAP, electronic documentation systems or other business systems.
• Training in Lean/6 Sigma/Kepner Tregoe or similar problem solving/decision making methodology. (Desirable)