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Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Sr Project Equipment Engineer


Reference:RH/A008940 Location: Dublin South
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Project Engineer

Project Equipment Engineer required for a contract role with a Dublin based Biopharmaceutical facility.


Role Summary:
The Project / Equipment Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Labelling and Packaging areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.



Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
  • Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will NOTAG from concept, through design, construction, commissioning and operation
  • Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
  • Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
  • Development and management of change controls
  • Participate as a member of multidisciplinary site and multisite teams
  • Development of detailed specifications, engineering documents, protocols and standard operating procedures
  • Execute, lead and participate in risk assessments associated with technology transfer of new products
  • Generation and Execution of FAT, Machibability and Functional Testing Protocols for New product introductions

Education and Experience:
  • Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
  • Typically, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment
  • Process development or technology transfer experience preferred.
  • Proven project management experience.
  • Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
  • Demonstrated experience in a GDP Compliant environment.
  • Experience in MS Office, MS Project, Change Control & Document Management Systems
  • Proven ability working cross functionally, delivering technical solutions and implementing improvements.
  • Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
  • Technical report writing and communication/presentation skills
  • Data driven decision maker
  • Ability to work to tight deadlines in a fast-moving environment




For more information contactRuth Hollandon087 7822 198or[email protected]