Johnson & Johnson
Technical Operations Specialist (Janssen)
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
I am recruiting for an exciting 12 month contract opportunity for a Technical Operations Specialist to join our expanding team in Janssen, Cork. Our ideal candidate will have at least 1 year post graduate experience within Validation preferably in Bio.
As Technical Operations Specialist, you will be responsible for the 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; Cleaning Validation, Autoclave Load Qualification and Validation, Process Validation Support (e.g. Mixing Studies, Media Challenge), Change Control, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, 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 other Technical Operations colleagues.
- 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 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.
- Participate in cross-functional teams as required.
- Educated to Bachelor’s 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
What you’re great at:
- Excellent interpersonal skills
- Ability to operate as part of a team is critical
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem-solving skills
- Results and performance driven
- Adaptable and flexible
- Integrity, trustworthiness and objectivity
- Knowledgeable of FDA/EMEA regulatory requirements
What you get in return:
- Flexible working hours across a 39 hour week
- Excellent rates of pay depending on experience