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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Downstream Investigations Specialist


Reference:AMC22428 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Manufacturing Engineer

Manufacturing Engineer - Downstream Investigations
11 month contract
Swords
AMC22428

We are currently looking for a manufacturing engineer to join the Downstream IPT team in a Biopharmaceutical manufacturer based in North Dublin.

Role responsibilities:

  • Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.
  • Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained.
  • Own Quality Investigation from identification through root cause analysis
  • Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance and material management as per area SOPs.
  • Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.
  • Act as a link between the shift operations team and days team, ensuring standardization and integration between all IPT teams.
  • Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.
  • Direct Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures.
  • Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required.
  • Provide ongoing coaching and support to cross functional team members, to share process and operational best practices.
  • Act as days operations member on process centered teams (PCT), working with technical operations and shift operations to identify, perform root cause analysis and develop corrective/ preventative actions for issues as they are occur.

Requirements:
  • A Level 7 Degree in Science, Engineering, or other relevant disciplines/ relevant experience preferable
  • Experiences across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.
  • Experience in change management in a GMP environment.
  • Experience in technical writing for GMP documentation and quality investigations.
  • Experience working with GMP Documentation Management Systems

If you are interested in this role apply today or get in touch with Angela McCauley at Life Science Recruitment