Amgen
Manufacturing
SeniorAssociate,Manufacturing
Neural analysis suggests this role is
optimal for Mid candidates.
“Senior Associate, Manufacturing at Amgen. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, GMP, quality system knowledge, troubleshooting, safety culture, documentation, training, lean principles, regulatory compliance. leading the shift in conjunction with FLM. outlining roles for the day”
What You'll Achieve.
achieve production targets efficiently in line with GMP, safety and regulatory standards; deliver to team, site and personal objectives
Industry & Context.
excellent troubleshooting skills using standard industry problem solving techniques; Proactively identify and resolve process issues (including escalation and follow up) to minimize production disruptions
required to work a shift pattern, This role will begin as a days position, moving to 24/5 shift pattern in the future
What They're Looking For.
Must Have
GMP and quality system knowledge, excellent troubleshooting skills using standard industry problem solving techniques, Educated to pass Leaving Certificate standard or equivalent, relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment, Significant experience in a GMP/other regulated environment, Demonstrated knowledge of GMP principles, Demonstrated aseptic knowledge in GMP areas, Drug product manufacturing experience, Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels, Demonstrated ability to deliver to team, site and personal objectives, Demonstrated understanding and use of right first-time techniques and lean manufacturing concepts, Results-oriented, Demonstrated ability to work within an AI Mindset, Excellent organizational, communicational and team development skills, understanding of the quality system requirements and regulations for working in an aseptic drug product facility, Excellent communication skills, Excellent computer skills - knowledge of Electronic Batch Records, Quality Management Systems and Performance management Systems, Fluent English required
Nice to Have
A third level qualification in a relevant subject area would be an advantage, Aseptic experience preferred, Team leadership experience
What You'll Do.
leading the shift in conjunction with FLM
outlining roles for the day
ensuring schedule is on track
Oversees opportunities from project from training perspective in project phase
Support development of SOPs/job-aids/guidance
Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP
safety and regulatory standards
Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule
Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans
up-to-date manufacturing schedule reflecting current status of production and plan critical path activities
Foster a good safety culture in our team and act as a safety role model
Oversee completion and review of documentation (batch records
EBRs) using relevant software systems and Standard Operating Procedures (SOPs)
Proactively identify training needs and facilitate completion of training to meet the area resource and cross training models
plan and implement continuous improvement initiatives using lean principles
Proactively identify and resolve process issues (including escalation and follow up) to minimize production disruptions
Support and assist with corporate
HPRA and other regulatory bodies during company audits
Lead on shift team in the absence of the Manufacturing Manager
How You'll Work.
Team & Collaboration
cross functional alignment on objectives and action plans; team development skills
Communication Scope
Excellent communication skills; communicational skills
Process & Methodology
plan critical path activities
Full Job Description
## **Career Category** Manufacturing ## ## **Job Description** **Manufacturing Senior****Associate – L4** **Amgen Dun Laoghaire** **Live** **What you will do** Let’s do this. Let’s change the world. 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 Senior Associate reports to the Manager Manufacturing. The ideal candidate will provide strong leadership to the Manufacturing teams. They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements as well as maintaining a strong culture of safety within their shift team and in the manufacturing area in general. The candidate will have excellent troubleshooting skills using standard industry problem solving techniques. The successful candidate will build on a culture of diversity, inclusion and belonging in fast-paced and evolving environment. The candidate will have a continuous improvement mindset to drive changes in efficiency, safety, compliance, and quality. The successful candidate will be required to work a shift pattern. This role will begin as a days position, moving to 24/5 shift pattern in the future. **Key Responsibilities:** * Responsible for leading the shift in conjunction with FLM. Responsible for outlining roles for the day, ensuring schedule is on track, triaging events, writing deviations, Batch Record Review. Running MDI’s. * Oversees opportunities from project from training perspective in project phase. * Support development of SOPs/job-aids/guidance. * Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and regulatory standards. * Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule. * Lead an assigned process area Work Centre Team (WCT) to
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