Amgen Specialist Manufacturing (MES) in Dun-Laoghaire-Rathdown, Ireland

Overview:

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.

Job Scope:

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.

Autonomy

  • 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

Compliance/Quality

  • 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.