Engineering , Science, Pharmaceutical & Food

Lead Bioprocess Associate – Shift

  • Contract
  • Remote
  • Meath
  • 41962950

PE Global is currently recruiting for a Lead Bioprocess Associate for a leading multi-national Biotech client based in Meath.

This is an initial 11-month contract shift position in a new state of the art single use multi-product biotech facility.

 

ROLE:

 

  • Carry out and support operations to achieve assigned duties.
  • Deliver shift standard work for a team-based approach to batch progression.
  • 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.
  • Initiate/ 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.
  • Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.
  • Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.
  • Effectively manage and schedule equipment shutdowns.
  • Ensure resources are available, thereby minimizing downtime.

 

REQUIREMENTS:

 

  • Minimum of a Bachelors Level 8 degree in Science, Engineering or other Technical Discipline.
  • 5 years experience in a GMP environment.
  • 3 years experience in Biopharma industry, with direct experience of biologics manufacture.
  • Proven record of accomplishments in a regulated industry required

 

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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