Upstream Manufacturing Process Specialist (hybrid)
AS0083
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.

This position is responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within Operations.

Duties:

• Represent Operations on cross functional project implementation teams.
• Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization.
• Monitoring and reporting of process performance using statistical process control.
• Troubleshooting of DCS (e.g Delta V) and PLC control systems.
• Investigating and resolving issues raised within the Manufacturing Department.
• Participate in/ Lead Cross Functional teams when required.
• Support of Commissioning and Qualification activities.
• Preparation and updating of Batch Records, Procedures and Work Instructions.
• Provide process and equipment related training as required within the Manufacturing Department.
• Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.

• Bachelors Degree in a scientific/technical discipline required.
• A minimum of 5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
• Industry experience in upstream fed batch bioreactors.
• Experience of DCS (e.g. Delta V), SCADA and PLC systems.
• Manufacturing experience within a GMP regulated environment.
• Experience of the cell culture or purification processes and Project / New equipment installation experience.