Job Title: Manufacturing Manager - MES
Location: Amgen Dun Laoghaire, Ireland
The Manufacturing Manager - MES will report to the Senior Manager of Manufacturing and be responsible for leading a team of MES designers in the generation of Master Batch Records (MBRs). This role ensures MBRs are delivered in compliance with Good Manufacturing Practices (GMP) and adhere to the Manufacturing Schedule. Additionally, this position will manage MBR delivery for New Product Introductions (NPI), Lifecycle Management (LCM), and revision of commercial records for ongoing production, along with updates from Capital Projects.
The ideal candidate will bring experience from the pharmaceutical or biotech industry and will have demonstrated leadership in managing complex MBR designs and delivering them in line with project timelines. This role requires broad technical experience in MES systems and MBR delivery, as well as a commitment to continuous improvement and the ability to handle multiple projects simultaneously.
Team Leadership & Management:
Recruit and onboard personnel to ensure the MES team can meet project targets while adhering to the manufacturing schedule. Monitor resource and training models to meet project needs.
Resource & Staff Management:
Assess and develop resource models for New Product Introductions (NPI) and Project siting assessments. Support ongoing recruitment and performance management to ensure the team delivers high-quality results.
Continuous Improvement:
Lead continuous improvement initiatives to enhance team efficiency and process effectiveness. Foster a culture of safety and performance excellence within the team.
Cross-Functional Collaboration:
Collaborate with other teams to ensure MBR designs align with business and project goals. Build strong relationships within the team and across functional areas to drive successful project outcomes.
MBR Development & System Improvement:
Support the Amgen Dun Laoghaire MES system by helping to develop and improve MBRs, review MES Standard Operating Procedures (SOPs), and implement improvements to the MBR process.
Audit Support & Compliance:
Assist with audits by regulatory bodies, including the FDA, HPRA, and others. Ensure that MES systems, MBRs, and processes are compliant with GMP and EH&S standards.
Training & Support:
Provide training and technical support for Electronic Batch Record (EBR) end-users. Offer expertise in troubleshooting and developing solutions to improve MBR and MES performance.
Change Control & Deviation Management:
Oversee adherence to timelines and metrics for change control and deviation processes. Lead and support investigations into deviations, ensuring timely resolution and regulatory compliance.
Equipment Integration:
Support the integration of shop floor equipment with the MES system for effective MBR interaction. Work with the core MES team to troubleshoot and develop new ways of working.
Education:
Experience:
Skills:
Apply Now to be part of Amgen’s mission to help patients live longer, healthier lives while advancing your career in biotech.
Visit careers.amgen.com to apply.
Equal Opportunity Employer Statement:
Amgen is an Equal Opportunity employer, committed to providing reasonable accommodations to individuals with disabilities. We celebrate diversity and inclusivity across all facets of our organization.
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