Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Technical Operations Specialist (Janssen)

Posted Jul 23, 2020
Job ID: JJJP00002852
Location
Cork , County Cork
Duration
5 months
(Aug 10, 2020 - Dec 31, 2020)
Hours/week
39 hrs/week
Payrate range
Unknown

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.


Experience:

  • 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
  • Innovative
  • 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



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