The Role:

ElevateBio is looking for an MES Specialist I to join the MES/LIMS team. This role reports to the Senior Manager, Operational Technology that is part of the OT team and the larger IT department. The MES team supports the various MES (Manufacturing Execution System) implemented at ElevateBio Basecamp and is constantly creating and updating recipes for contract manufacturing. As needed, an MES Specialist I may support the LIMS (Laboratory Information Management System) as part of the MES/LIMS team.

Here’s What You’ll Do:

A successful MES Specialist:

• Creates and updates recipes/batch templates that can be used for manufactured products or for tracking equipment-related activities.
• Collaborates with Manufacturing, Technical Operations (MSAT), and Quality Assurance to understand the requirements for recipes/batch templates.
• Authors, executes, reviews, and approves validation testing/verification for recipes/batch templates.
• Participates in the team on-call rotation which supports 24/7 manufacturing operations.
• Provides basic LIMS support as needed to support the MES/LIMS team, though this is not a core job responsibility.
• Understands recipes/recipe structure.
• Understands process documents in “normal” language and translates into “technical” language.
• Explains technical topics in varying levels of complexity.
• Creates training content and performs/facilitates training sessions.
• Communicates and collaborates with other team members within IT, Manufacturing, Quality Assurance, Technical Operations/MSAT, and Supply Chain to work on department and company goals.

Requirements:

• 2+ years of manufacturing/Tech Ops/MSAT experience; Must have an understanding of a manufacturing area of specialization and GMP regulations.
• Experience within cell & gene therapy, biologics, and/or contract manufacturing organizations is a bonus.
• Previous MES or MOM (Manufacturing Operations Management) experience with any platform, e.g. Apprentice, Tulip, PAS-X, Syncade, PharmaSuite, POMSnet; MES experience must include recipe authoring (creating or updating master recipes, batch templates, equipment logbooks, procedure templates).
• Experience with MES system administration (e.g. user account creation, MES-SAP interface troubleshooting) is a bonus.
• Experience with using SAP or understanding SAP workflows, especially around process orders, goods issues, and goods receipts, is a bonus.
• Proficient at using Microsoft Office, especially Visio and Excel.
• Comfortable delivering trainings, facilitating workshops, and presenting to groups of people.
• Experience explaining and “translating” process topics to technical people and technical topics to non-technical people.
• Effectively executes assignments and proactively identifies steps in straightforward situations.
• Works on moderately difficult assignments with some latitude to determine the direction and approach.
• Performs work with limited supervision and receives general instructions on most new work. Also has some experience working independently with limited instructions and requirements.
• Takes a broad perspective to problems to ideate, define, and communicate solutions based on best practices.
• Provides feedback on existing work and makes suggestions for new projects and initiatives.
• Identifies and escalates issues that have potential impact to MFG operations, product impact, or GMP compliance/data integrity.
• Proactively seeks resources to build on own experience, including learning MES best practices and understanding workflows within manufacturing, Tech Ops, Supply Chain, and other groups.