What are the responsibilities and job description for the Mes specialist position at Regeneron Pharmaceuticals, Inc?
We are currently recruiting for an Associate MES Production Specialist who would collaborate closely with MES Operations and Manufacturing to ensure the continual generation, revision, and approval of MES documentation.
A typical day may include the following :
Supports MES builds by generating support documentation (e.g process flow map templates) from review of SOPs, SPECS, and Manufacturing Batch Records
Collaborates with Manufacturing and MES Operations in review of MES documentation
Reviews data for creation of OPM recipes to support the MES builds
Provides documentation to support MES change controls
Collaborates in the creation, review and approval of Electronic Batch Records
Supports the build of MES recipes, workflows, and batch records to meet the requirements of Manufacturing and QA users
Coordinates team on field testing of MES documents with MFG SMEs
Supports Manufacturing in working with MES at a basic level
Coordination with Area Owners to ensure process area readiness for MES deployment (hardware, barcoding etc.)
Leading MFG element of release activities in the lead up to MES records
Coordinate KPI data to aid wider MES / MFG team in driving consistency and timeliness
You coordinate upgrade tasks on laptops e.g. laptop replacement / delivery and wipe in
You provide on the floor support to Manufacturing during MES deployment
You lead coordination of activities as part of wider MES team live on the production floor
This role may be for you if :
You have knowledge of BioPharma Manufacturing and GMP requirements as well as knowledge of MES systems.
You can identify difficulties and works to develop solutions
You can work with Manufacturing to resolve priority of MES Implementation
You enjoy logical troubleshooting and problem-solving skills
You have analytical, written and verbal communication skill
To be considered for this role you must have : Requires a BS / BA in a related field and the following minimum years of relevant experience for each level or equivalent combination of education and experience.
MES Production Specialist I : 0-2 years of relevant experience
MES Production Specialist II : 2 years of relevant experience
MES Production Specialist III : 5 years of relevant experience
MES Production Specialist IV : 8 years of relevant experience
Level will be determined based on qualifications relevant to the role.
Last updated : 2024-04-30