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Details

Technical Operations Cleaning Validation Specialist


Reference:SMC035740 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Snr Validation 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

• 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.
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• 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 engineering, construction and commissioning activities.
• 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.
• Participate in cross-functional teams as required.
• Deputise for the Technical Operations Lead or other team member where required.
• Domestic and international travel may be required.

Education & Experience

Essential
• Bachelors Degree in a scientific/technical discipline required
• Focus on patients and customers at all times.

Desirable:
• Cleaning Validation Experience.
• Experience in a large molecule start-up facility.
• Experience in other Validation areas (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Process Validation).
• 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