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As part of Amgen’s Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients. The PM3 Syringe Manufacturing Senior Associate (16x5 shift) reports to the Front Line Manager or Senior Manager and is responsible for ensuring 24/7 operational continuity and standardization.
Job Responsibility:
Ensuring Safety, Quality and Compliance
Takes a proactive approach to safety, quality and compliance
Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits
Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP’s and to GMP standards
Review manufacturing batch documentation both paper and electronic in a RFT manner
Support deviation management and investigations at various levels
Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support
Supporting the creation of short and medium- schedules and being accountable for the on time in full execution against the plan
Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan
Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables
Using project management principles to lead complex cross functional initiatives
Supporting cross functional engineering, Process development and maintenance teams to improve the reliability of existing equipment
Recognising positive performance and sharing best practices with other shifts, departments, and sites within the network
Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans
Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognise positive contributions
Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance related deviations
Leading lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement
Effective communication skills both written and orally with the power to influence at various levels of the organisation
Providing manufacturing performance and project updates at various forums to audiences including senior leadership
Escalating any issues which cannot be resolved locally in accordance with Amgen’s escalation policy.
Requirements:
Working knowledge of aseptic or GMP manufacturing operations
Typically, 2 – 5 years’ experience in a GMP environment
Bachelor’s degree in relevant science or engineering related discipline
Be a results-oriented person with excellent organizational, communicational and team development skills
Demonstrated ability to deliver to team, site and personal objectives
Demonstrated understanding and use of RFT techniques and lean manufacturing concepts
Strong ability to lead, challenge and positively influence in an interactive team environment
Strong computer skills - knowledge of Electronic Batch Records, PAS-X, Lims, etc.
Nice to have:
Have the ability to influence and lead cross functional teams to deliver both tactical and strategic objectives
Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates.
What we offer:
Total Rewards Plan designed to support your health, financial wellbeing, work/life balance, and long-term career growth
Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents, retirement and savings plan with generous company contributions, group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development, and career advancement opportunities.