Senior Biopharmaceutical Operations Specialist

3 days ago


Dublin, Dublin City, Ireland beBeeProcess Full time €60,000 - €80,000
Biopharmaceutical Project Manager in Ireland

An exciting opportunity is now available to work on one of the largest biopharmaceutical projects in the country.


Job Overview:

We are seeking a highly skilled and experienced Process Lead to join our team in Dublin, Ireland.


Key Responsibilities:
  • Set technical direction and ensure overall accountability for the entire scope of work from initial concept through to successful operation.
  • Act as Technical Decision Maker for their area of scope.
  • Review, accept, and approve key technical documentation such as User Requirements Specifications, Process Design Inputs, Factory Acceptance Tests, and Site Acceptance Tests protocols.
  • Work closely with the receiving team to ensure a smooth transition and beneficial operation.
  • Ensure User Requirement Specifications are produced and complete, technically accurate, and appropriate for calibration and qualification execution.
  • Provide strategic leadership to process improvement programmes using LEAN and Change Management tools.
  • Maintain business continuity and flag areas of concern.
  • Support planning and implementation of commissioning and qualification activities.
  • Lead process risk assessments to establish and deliver safe process operations and have compliance when manufacturing products to quality standards.

Desirable Experience:
  • Experience with API (Small molecule) & Process design.
  • Strong stakeholder management.
  • Assess equipment needs and support generation of equipment specifications for design or purchase.
  • Experience with GMP User Requirements Specifications, which will be agreed with project stakeholders in basic design.


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