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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Lead Manufacturing Biotech Associate


Reference:RK21949 Location: Meath
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Coordinator

Lead Manufacturing Biotech Associate
RK21949
Contract – 11 months
Meath


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The Lead Manufacturing Biotech Associate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset



Duties:

  • Carry out and support operations to achieve assigned duties.
  • Deliver shift standard work for a team-based approach to batch progression.
  • Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
  • Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
  • Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
  • Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
  • Provide coaching to the shift teams on the RFT approach to documentation.
  • Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
  • I nitiate/ maintain housekeeping in all work areas.
  • Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
  • Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.
  • Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
  • Coach and provide oversight on the shop floor to identify potential issues before they arise.
  • Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables.
  • Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
  • Lead straight-through document accuracy metrics and the development of a CI framework.
  • Support site functional initiatives to improve compliance status and operational efficiency of the site.
  • Run handover boards and provide key updates to shift leads for handover.
  • Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving, CI projects and assist with the resolution of issues/ delays.


Experience and Education:
  • Bachelors Level 8 degree in science, engineering or other technical discipline, or a Level 7 qualification in a science or engineering discipline
  • 5 years’ experience in a GMP regulated environment.
  • Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures.



If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.