MES Specialist

Fujifilm • Madison, WI

12h

About The Position

The MES Specialist supports day-to-day operations of the Körber (Werum) PAS-X Manufacturing Execution System on and off the manufacturing floor. This role assists in recipe and batch record updates, coordinates routine changes with Manufacturing and QA, delivers basic MES training to end users, and provides EBR and process support during production. The Specialist works across multiple facilities to support NPIs and campaign activities in clinical and commercial cell therapy manufacturing. The ideal candidate is a collaborative problem solver who learns quickly, follows established procedures, and delivers compliant changes with guidance from senior team members.

Requirements

• B.Sc. with 2–4 years; or Associate with 3–5 years; or High school diploma with 4–6 years of relevant experience in GMP manufacturing IT, MES, or related systems.
• Experience with MES in GMP environments required; direct Körber PAS-X experience preferred (candidates with other MES platforms strongly considered with commitment to learn PAS-X).
• Foundational experience configuring or supporting MES (preferably PAS-X), including basic recipe/MBR updates, testing, and issue resolution.
• Hands-on L1/L2 application support, including: ServiceNow (or similar) for incident/request/change management and SLA adherence.
• Basic troubleshooting, log review, and data/configuration fixes under supervision.
• Experience working with QA/QMS processes; exposure to EtQ and/or Veeva QMS for deviations, CAPA, and change controls preferred.
• Ability to analyze operational data and prepare concise technical summaries/reports.
• Understanding of CSV principles, risk-based testing, and documentation practices in GxP environments.
• Strong communication, organization, and time management; ability to follow standards, take direction, and escalate promptly.
• Comfort supporting manufacturing floor operations and rotating support coverage as needed.
• Participation in external communities (e.g., PAS-X RUGs) and willingness to share learnings internally.

Nice To Haves

• Coding or scripting exposure is a plus but not required.
• Familiarity with PAS-X modules such as MBR Designer, EBR/SFC, Weigh & Dispense, Inventory, or Labeling is a plus.
• Exposure to integrations or operations alongside SAP (ERP) and LabWare (LIMS) is a plus.
• Experience with cell counting systems (e.g., Cellaca) is a plus.

Responsibilities

• Assist with configuration and maintenance of PAS-X MES recipes and associated electronic/paper batch records under guidance.
• Update and maintain master data and MBRs for engineering, clinical, and commercial use following approved templates and standards.
• Execute unit and functional testing for recipe/configuration changes and document results.
• Provide day-to-day L1/L2 support for PAS-X, including ticket triage, user assistance, and basic troubleshooting; escalate complex issues to senior staff or vendor support as needed.
• Use ITSM practices in ServiceNow or similar ticketing system (incident, request, and change management) with accurate ticket documentation and SLA adherence.
• Perform routine system administration tasks (user/role provisioning, access reviews, job/queue monitoring, log checks, housekeeping) with supervision.
• Support releases, hotfixes, patching, and upgrades in non-prod and production environments by executing pre-defined steps and validation tests.
• Partner with Manufacturing, QA, IT, and Validation to coordinate and execute controlled changes to batch records and master data.
• Participate in floor support during manufacturing to address MES-related issues, data entry questions, and EBR holds.
• Contribute to standardization and harmonization of MES templates and procedures across facilities by applying approved governance.
• Follow cGMP, 21 CFR Part 11/Annex 11, and data integrity (ALCOA+) requirements in daily work.
• Draft or contribute to CSV deliverables (e.g., URS input, test scripts, evidence capture) and execute testing (IQ/OQ/PQ support) under a validated framework.
• Create or support quality records in QMS platforms (e.g., Veeva, EtQ) for deviations, CAPAs, and change controls; progress actions on schedule.
• Deliver basic MES training for end users and super users; support onboarding and refresher sessions.
• Author and maintain SOPs, WIs, and knowledge articles (job aids, FAQs, troubleshooting guides) to enable self-service and faster resolution.
• Identify and log opportunities to reduce exceptions, improve right-first-time, and streamline data entry and workflow steps.
• Participate in root-cause investigations and implement corrective/preventive actions with senior guidance.
• Contribute to work planning using a pragmatic mix of Waterfall (CSV stage gates/deliverables) and Agile/Scrum practices (stand-ups, backlog updates, demos) to deliver compliant changes quickly.
• Support cutovers, hypercare, and knowledge transfer with clear acceptance criteria defined by the team.
• Adhere to industry best practices.
• Self starter with minimal instruction.

Benefits

• FUJIFILM is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
• If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED