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Process & Equipment Engineer

Job description

Process & Equipment Engineer

Job Description

My client, an established Biologics manufacturing multinational in South Dublin, is recruiting for a Process & Equipment Engineer to join their team.

The role is a contract position with excellent rates and opportunity for long-term placement.

As a member of the Process & Equipment Engineering team, the role will support complex and challenging manufacturing initiatives.

This is an office hours M-F position and requires experience with syringe filling and packaging machines.

Key Responsibilities:
  • Ownership of equipment/systems in a GMP regulated manufacturing setting
  • Support Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Inspection, Component Preparation and Packaging areas
  • Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
  • Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems
  • Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs
  • Solving complex problems, project management, equipment lifecycle management and operational excellence
  • Develop and manage change control requests per established SOPs and processes
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
     
Preferred Qualification
  • Bachelors in Engineering (Mechanical, Electrical or Chemical)
  • Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
  • Solid leadership, technical writing, and communication/presentation skills
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices
  • Experience in developing strategies for new product introduction and new technology deployment
  • Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
  • Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
  • Ensure application of corporate blueprint and standards using business drivers to local business needs
  • Development and presentation of project plans to senior management
  • Day to day vendor management and contract negotiations with focus on equipment suppliers
  • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
  • Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
     
Travel at various times may be required to support execution of projects