Description
The Technical Operations Specialist 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 (eg Steam-In-Place PQs), Process Validation Support (eg 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 (eg 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.
Education, Skills and Experience
- Bachelors Degree in a scientific/technical discipline
- Focus on patients and customers at all times.
- Experience in Validation (eg Performance Qualification (eg Steam-In-Place PQs), Process Validation Support (eg 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.
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
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