• Cork

Initial 12-month contract role.

 Job Purpose

We have an exciting opportunity for a Technical Operations Specialist to join our expanding team in Cork to help support the Technical Operations unit.

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 and Lifecycle Management area. Secondary activities include, but are not limited to, Cleaning Validation, Process Validation Support (e.g., Mixing Studies, Microbial Hold Studies, Media Challenges), 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).

Role focus: Managing the process and lifetime of products through the delivery of CPV and Lifetime documentation, supporting APRs, performing process data analysis and problem solving. Supporting activities associated with process and lifetime management.

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

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, manual and automated reports).
  • Statistically analyse data and troubleshoot problems with other departments.
  • 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.

Be vital:

  • A level 8 Bachelor’s Degree in a scientific/technical discipline required
  • Always focus on patients and customers.
  • Lifetime program experience is desirable– monitoring lifetime of resins in columns. CPV (Continuous Process Verification) – monitoring of batches for various parameters and generating CPV report to ensure everything has remained within criteria. There is a statistical element – use of MINITAB.

Desirable:

  • Experience in Manufacturing (e.g., Supporting: Process Improvement Projects / Process Validation campaigns/Root Cause Problem solving/ Statistical data analysis)
  • 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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