Biopharma Operations Specialist

4 days ago


Limerick, Limerick, Ireland PM Group Full time
About the Role

This is an exciting opportunity to join our team as a Project Engineer and contribute to the delivery of CAPEX projects at a biopharmaceutical manufacturing facility. As a Project Engineer, you will be responsible for leading and supporting the management and execution of projects.

Responsibilities
  • Lead the end-to-end delivery of engineering CAPEX projects from concept to completion
  • Develop comprehensive project scopes, objectives, schedules, budgets, and resource plans
  • Cross-functional collaboration with manufacturing, quality, regulatory, and safety teams
  • Design specification development and layout coordination with internal stakeholders and external engineering firms
  • Technical expertise provision during design, installation, and commissioning
  • RFP preparation and supplier bid evaluation
  • Vendor and contractor performance management
  • Procurement of equipment, materials, and services for project execution
  • On-site activities supervision for safe, efficient, and high-quality construction practices
  • Commissioning plan development, including equipment testing, system integration, and performance verification
  • Validation activity coordination to meet GMP and regulatory requirements
  • Project budget monitoring, expenditure tracking, and financial performance reporting
  • Risk identification and mitigation, including scope changes and schedule impacts
  • Status updates, technical reports, and project documentation preparation
  • Compliance with local and international regulatory standards
  • Safety culture promotion throughout all project phases


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