Technical Operations Engineer
Posted on Oct 8, 2019 by Elevate Direct
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.
If you match these requirements, please apply in the usual way. Elevate will send you an email, please open, click and action that email as soon as possible. Once the application process is completed within Elevate, your application will then visible to the hiring recruiter. If you don't complete the process in Elevate you will not be visible to the recruiter or hiring manager.
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