Amgen Specialist Manufacturing (MES) in Dun-Laoghaire-Rathdown, Ireland
The Manufacturing Specialist (MES) - will report to the Manager Manufacturing (MES) and will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate will have at least five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading teams to deliver complex MBR designs in time with project timelines.
The ideal candidate will have:
Broad technical experience in MES systems.
Experience of working in syringe/Vial manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.
The ability to adapt quickly to the demands of syringe/Vial filling.
MES Technical Expertise
Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions.
Responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
Responsible for the support and ongoing development of the Amgen Dun Laoghaire MES system in development of MBRs and improving the MES business process.
Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
Responsible for the development, review and update of MES Standard Operating Procedures.
Responsible for the preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner etc.
Accountable for adherence to established timelines and metrics for the change control and CAPA process.
Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens, Rockwell, Kepware OPC Server
Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
Liaison with Amgen MES core-team to troubleshoot and develop new ways of working
Responsible for providing technical support where required and as directed by Operations leadership
Other Responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.
Accountable for Delivering Results by:
Ensuring that all metrics relating to schedule, output, quality, safety and reporting are met.
Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables.
Accountable for work which is guided by operational and project objectives and with minimal supervision
Manage multiple assignments and processes
Independently determine approach to projects
Independently develop solutions that are thorough, practical and consistent with functional objectives
Partners and communicates effectively with other departments and support functions to ensure positive working relationships.
Extends capabilities by working closely with senior staff / experts within and outside organisation
Contribute to and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture
Knowledge and Problem Solving
Broad knowledge within own speciality area
Accountable for enhancing own knowledge through understanding business trends and objectives
Knowledge of industry and business principles
Understands the core business process and purpose of the functional area in Amgen's commercialisation process
Handles diverse scope of issues that require evaluation of a variety of factors including current business trends.
Implement, assign, lead or participate in projects and develops own project management techniques
Applies analytical skills to evaluate and interpret complex situations / problems using multiple sources of information
Anticipates and prevents potential problems
Forecasts, models and utilises advanced analytical tools
Qualitative information, Quantitative research and Trend data
Basic Qualifications & Relevant Experience preferred:
Bachelor's degree in Engineering or Science
Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing
Knowledge of regulation requirements (GMP & EH&S)
Typically 5 - 10 years' experience in an aseptic pharmaceutical environment.