Career Category

Job Description

Overview:

The Manufacturing Specialist (MES – Manufacturing Execution System) role is a key communication and technical interface for the ARI Drug Substance facilities.  The Amgen Rhode Island Manufacturing site supports two Drug Substance facilities and serves a critical role in Amgen’s commercial manufacturing network.  The successful candidate will be responsible for ownership and oversight of the MES system at ARI.  The successful candidate will have five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading projects and teams to deliver MES designs within project timelines. 

The ideal candidate will have:

• Broad technical experience in MES systems
• Experience with PAS X, Werum software
• Experience of working in bulk manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology
• The ability to adapt quickly to the demands of commercial manufacturing operations
• Extensive experience with electronic documentation systems in a regulated environment

Job Scope:

Manufacturing Execution Systems (MES) Lead will be responsible for the design, authoring, implementation and validation of the Electronic Batch Records used in the plants.  Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.  Provide business oversight of the MES system across the site.

• Represents the plant on global MES network and initiatives
• Liaison with Amgen MES core-team to troubleshoot and develop new ways of working.
• Responsible for the support and ongoing development of the Amgen MES system in development of MBRs and improving the MES business process.
• Responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design
• Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff)
• Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - DeltaV
• Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
• Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions
• Responsible for providing technical support where required and as directed by Operations leadership

Project Management and Team Building

• Experience in cross functional Project Management
• 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 organization
• Ability to coach, mentor and/or cross train colleagues within core technical areas

Compliance and Quality

• Own and manage deviations, corrective actions and change controls related to MES and related areas
• Contribute to and assist with Corporate, FDA, and other regulatory bodies during company audits
• Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant
• 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

Basic Qualifications & Relevant Experience preferred:

• Master’s degree in Engineering or Science and 3 years of Manufacturing experience

OR

• Bachelor’s degree in Engineering or Science and 5 years of Manufacturing experience

OR

• Associate’s degree in Engineering or Science and 10 years of Manufacturing experience
• Working knowledge of manufacturing in pharmaceutical/biotech industries
• Knowledge of regulation requirements (GMP & GAMP)