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Senior Manufacturing Process Specialist

Reference:SMC0063
Location: Cork
Qualification:Degree
Experience:See description
Job Type:Fixed Term Contract
Salary:Not Disclosed
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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.

Duties

• 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

PLEASE APPLY DIRECTLY BY CLICKING HERE

Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.

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