Sr. Associate Manufacturing - Level 4 - Amgen Dun Laoghaire - Co. Dublin Overview: The PM3 syringe manufacturing Sr Associate will report to the front line manager (FLM) and will be responsible for ensuring continuity and standardisation 24x7 of operations. The ideal candidate will have at least 2-5 years of experience within the pharmaceutical or biotech industry. The ideal candidate will have: • Working knowledge of aseptic or GMP manufacturing operations • Have the ability to influence and lead cross functional teams to deliver both tactical and strategic objectives to ensure patient supply today and into the future. • Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates. Job Scope: • Ensuring Safety, Quality 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.