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Mes Production Specialist
4 months ago
**Summary**: Responsible for liaising with MES Operations and Manufacturing to ensure the continual generation, and revision, and approval of MES documentation documentation.
Essential Duties and Responsibilities include, but are not limited to, 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
Participate in Pre-PE executions (Static and Dynamic) and testing of MES records
Supports the build of MES recipes, workflows, and electronic batch records to meet the requirements of Manufacturing and QA users
Coordinates team on field testing of MES documents with MFG SMEs
Identifies difficulties and works with MES Operations and Manufacturing to develop solutions
Coordination with Area Owners to ensure process area readiness for MES deployment (hardware, barcoding etc.)
Coordinate upgrade tasks on laptops e.g. laptop replacement /delivery and wipe in
Collaborates with Manufacturing and MES Operations in review of MES documentation
Identifies difficulties and works with MES Operations and Manufacturing to develop solutions
Provides documentation to support MES change controls. Leading MFG element of go-live activities in the lead up to MES records live on the production floor
Provides on the floor support to Manufacturing during MES deployment
Leading coordination of hyper care activities as part of wider MES team go-live on the production floor
Monitors KPI data to aid wider MES/MFG team in driving consistency and timeliness
Collaborates in the creation, review and approval of Electronic Batch Records
Supports Manufacturing in interfacing with MES at a basic level
Supports the build of MES recipes, workflows, and electronic batch records to meet the requirements of manufacturing and QA users.
Works with Manufacturing to determine priority of MES Implementation.
Provides on the floor support to Manufacturing with oversight from MES Operations when applicable.
**Knowledge and Skills**:
Knowledge of BioPharma Manufacturing and GMP requirements
Knowledge and experience of MES preferably Werum PAS/X
Logical troubleshooting and problem-solving skills
Analytical, written and oral communication skills
Defines user requirements.
**Education and Experience**:
**MES Production Specialist I**: BS/BA in a related field with 0-2 years of relevant experience
**MES Production Specialist II**: BS/BA in a related field with 2+ years of relevant experience
**MES Production Specialist III**: BS/BA in a related field with 5+ years of relevant experience
**MES Production Specialist IV**: BS/BA in a related field with 8+ years of relevant experience
Relevant experience may be considered in lieu of the educational requirement.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Salary Range (hourly) $20.77 - $42.93
