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Details

Technical Operations Engineer


Reference:SMC00034836 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Technical Specialist

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

Summary

Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP). These activities include, but are not limited to, Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation, Change Control, Exception/Event Investigations/Closure.

Duties

• Conduct Technical Operations activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
• Develop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, reports).
• Review and approve documents prepared by the Technical Operations.
• Execute Technical Operations protocols as required.
• Prepare reports for executed protocols for review and approval.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions/events/deviations during Technical Operations activities.
• Prioritize Technical Operations activities in line with the project schedule.
• Co-ordinate Technical Operations activities with contractors and vendors as required.
• Co-ordinate Technical Operations document review and approval.
• Collate and organize Technical Operations files for turnover to QADC.
• Attend identified training, required to fulfill the role of a Technical Operations Specialist.
• Assist in the development of training material for Technical Operations activities.
• Domestic and international travel may be required.

Experience & Qualifications

• Bachelor’s Degree in a scientific/technical discipline required
• Experience in Validation (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation).
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

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

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