• Anywhere

Initial 18-month contract role with view to long term.

Job Purpose

We have an exciting opportunity for a Technical Operations Specialist to join our Technical Operation Project involved in the Site expansion project.

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). Primary activities are in the Process Validation area. Secondary activities include, but are not limited to, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Cleaning Validation, Manufacturing 2nd Line Support of commercial products, Supporting process improvement projects / Commercial Product scale up projects / New technology deployment, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).

As a Technical Operations Specialist, your typical day may include

  • Conduct Technical Operations activities in compliance with US and EU regulations, company 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.
  • Liaise with Manufacturing to provide support where required with routine operations / project-based work
  • 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 Manufacturing / the particular 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.

Requirements

  • A level 8 or higher degree in a scientific/technical discipline required
  • Experience in biological Process Validation or biological manufacturing.
  • Experience in Projects, New product introduction (e.g. Supporting: Process Improvement Projects / Process Validation campaigns)
  • 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.

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