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Principal Engineer – Vial Filling

4 weeks ago

Dublin, Ireland Amgen SA Full time

Reporting to the Engineering Snr. Manger, this person is accountable for leading a team supporting commercial manufacturing with a focus on Vial filling equipment. The position will support complex and challenging manufacturing initiatives.

Key Responsibilities:

  1. Provide tactical as well as strategic management and leadership to provide operational support and project completion, mentoring, staff development, team productivity and efficient use of available resources.
  2. Planning support structures with internal/cross-functional teams for capital projects, goals and network initiatives execution. Providing input into department objectives and establishment of strategic direction within the F&E team.
  3. Lead the direction for vial filling unit operations as it relates to the equipment; work together with the system owners to ensure both urgent day-to-day equipment reliability issues are resolved as well as longer term focus areas are planned for appropriately.
  4. Maintain and improve plant capability and equipment reliability in partnership with F&E and plant leadership and other technical staff in the network with a focus on “predict and prevent” systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment maintenance.
  5. Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements.
  6. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.
  7. Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects and implement.
  8. Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure that all staff are adequately trained and follow all GMP standards and procedures.
  9. Support Business Continuity Plans by identifying gaps and develop/implement solutions to close the gaps.
  10. Develop and adhere to department budgets and spend for operational and capital expenses.
  11. Be knowledgeable and current on compliance and regulatory aspects for operation and maintenance, equipment validation and support regulatory inspections and audits.
  12. Support a safe working environment by complying with all pertinent environmental health/safety practices, rules and regulations.

Preferred Qualifications:

  1. Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical)
  2. Manufacturing experience in biopharmaceutical Formulation/Fill/Finish
  3. Solid leadership, technical writing, and communication/presentation skills
  4. Experience in change control, non-conformance, corrective and preventative actions, and validation practices
  5. Experience in developing strategies for new product introduction and new technology deployment
  6. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
  7. Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
  8. Ensure application of corporate blueprint and standards using business drivers to local business needs
  9. Development and presentation of project plans to senior management
  10. Day to day vendor management and contract negotiations with focus on equipment suppliers
  11. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
  12. 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.

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