Technical Operations Engineer - Validation
Our client, a pharmaceutical company in Cork are currently looking to recruit a Technical Operations Engineer for their site on a contract basis.
The Technical Operations Specialist/Engineer will be responsible for the following.
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.
As a Technical Operations Specialist, your typical day may include:
- 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 fulfil 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.
- To Bachelors Degree in a scientific/technical discipline required
- Focus on patients and customers at all times.
- 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.
For further information on this Technical Operations Engineer role in Cork please contact Caroline Kingston on 086 8395531 / email@example.com
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