Manufacturing Specialist (MES) – REF 02043MQ

Headcount Solutions is sourcing a Manufacturing Specialist (MES) for our client’s biotech facility in Dublin. This person will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design.

Responsible for:

·            Development, configuration and testing of Master Batch Records (MBRs) from initial to final design.

·            Lead MBR development design reviews including liaising with Operations, Process Development and Quality functions.

·            Drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.

·            Support and ongoing development of the MES system in development of MBRs and improving the MES business process.

·            Training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).

·            Development, review and update of MES Standard Operating Procedures.

·            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.

·            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.

·            Resolving interface errors and stock discrepancies between ERP/MES as required.

·            Providing technical support where required and as directed by Operations leadership.

Requirements:

·            Bachelor’s degree in Engineering or Science.

·            5+ years experience in an aseptic pharmaceutical environment.

·            Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing.

·            Knowledge of regulation requirements (GMP & EH&S).

·            Advantageous to possess experience of working in syringe/Vial manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.

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