Senior Associate Manufacturing (PM3)

Amgen Inc.

3.6

(9)

Dublin, Ireland

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-205741

    Position summary

    uality and Compliance

    o Takes a proactive approach to safety, quality and compliance and actively seeks opportunities to prevent adverse events from occurring.
    o Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits.
    o Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP's and to GMP standards.
    o Review manufacturing batch documentation both paper and electronic in a RFT manner to support timely release to support shipping and disposition cycle time (DCT) commitments.
    o Support deviation management and investigations at different levels.

    • Accountable for Delivering Results by:
    o Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support.
    o Supporting the creation of short and medium- schedules and being accountable for the on time in full execution against the plan.
    o Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan.
    o Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables.
    o Using project management principles to lead complex cross functional initiatives.
    o Supporting cross functional engineering, Process development and maintenance teams to improve the reliability of existing equipment.
    o Recognising positive performance and sharing best practices with other shifts, departments and sites within the network.
    o Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans.
    o Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognise positive contributions.
    o Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance related deviations.
    o Leading lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement.

    o Accountable for Communication and Escalation

    o Strong communication skills both written and orally with the power to influence at different levels of the organisation.
    o Providing manufacturing performance and project updates at various forums to audiences including senior leadership.
    o Escalating any issues which cannot be resolved locally in accordance with Amgen's escalation policy.

    • Basic Qualifications & Relevant Experience preferred:

    o Typically, 2 - 5 years' experience in a GMP environment
    o Bachelor's degree in relevant science or engineering related discipline.
    o Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.
    o Demonstrated ability to deliver to team, site and personal objectives.
    o Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.
    o Strong ability to lead, challenge and positively influence in an interactive team environment.
    o Strong computer skills - knowledge of Electronic Batch Records, PAS-X, Lims, etc.

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging