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Senior Manufacturing Process Specialist

Reference:SMC0063 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Process Engineer

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.


• Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
• Monitoring and reporting of process performance using statistical process control
• Generation of data and reports to support Annual Product Reviews and Regulatory submissions
• Troubleshooting of DCS (e.g Delta V) and PLC control systems
• Investigating and resolving Deviations 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
• Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
• Completion of all documentation in compliance with site procedures and GDP.
• Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
• Generate and assist with generation, review and revision of Manufacturing documentation as necessary.
• Support ongoing studies by Validation, OTS and other support functions.

Education & Experience

• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
• Manufacturing experience within a GMP regulated environment.
• Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment.
• Experience of the cell culture or purification processes in either a manufacturing or a lab based environment.
• Experience of DCS (e.g. Delta V), SCADA and PLC systems
• Experience of SAP, LIM’s and/or other business systems.
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.

If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480


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