Principal Systems Specialist

2 days ago

Dublin, Dublin City, Ireland beBeePharmaceutical Full time €60,000 - €70,000
Project Engineer Role Overview">

Located on the picturesque west coast of Ireland, our state-of-the-art pharmaceutical facility is looking for a Project Engineer to join our team. With a $55 billion investment in research, we are pursuing scientific breakthroughs and changing people's lives.

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  • Essential Duties:
    • Perform process and equipment reviews, prepare technical reports detailing equipment operation and best practices, and recommend new equipment or process changes that will result in quality improvement or cost reduction.
    • Develop user requirement specifications, technical specifications and design specifications for replacement equipment or upgrades to existing equipment and select correct design concepts and the fundamental technology to be used for new equipment or improvement of existing equipment.
    • Manage the execution of the project plan, including change control management, coordinating project activities of the department and other internal and external resources, and monitoring and reporting project status and cost.
    • Develop plan for equipment qualification.
    • Author and execute equipment qualification protocols (IQ OQ).
    • Support and adhere to established processes and productivity targets.
    • Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
    • Recognise and report to immediate supervisor any issues or deviations from accepted standards.
    • Provide status updates on own activities and productivity challenges according to defined procedures.
  • Desirable Experience:
    • Bachelors Degree in Engineering or equivalent combination of education and work experiences required.
    • Extensive experience and nor training; or equivalent combination of education and experience.
    • Experience in pharmaceutical manufacturing and packaging equipment and/or pharmaceutical processing equipment design, evaluation, and specification is an advantage.
    • Detailed understanding of P&IDs, process flow diagrams, and all related pharmaceutical commissioning and qualification documentation.
    • Experience working with pharmaceutical processing technologies and good understanding of 2ICFR cGMP documentation and electronic systems requirements.
    • Demonstrated experience applying sound engineering principals and critical reasoning to troubleshoot complex process and engineering challenges.
    • Proficiency of computer skills with Microsoft Word, Excel, Outlook, CAD.
    "],

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