MES Business Analyst

We are looking for an MES Business Analyst with strong Apprentice Tempo knowledge to work between manufacturing teams, compliance and technical teams at a regulated pharmaceutical site. You will turn shop floor needs into clear requirements and see them through testing and release.

Responsibilities

• Gather requirements from manufacturing, shop floor, quality, warehouse and supply chain teams
• Lead MES business and process analysis, with a focus on Apprentice Tempo
• Develop as is and to be process maps, functional requirements, user stories and acceptance criteria
• Perform fit gap analysis across MES, LIMS, SAP or ERP, and manual processes
• Plan and support testing, UAT and validation, and drive defect resolution to closure
• Make sure solutions meet GxP, GMP, 21 CFR Part 11, ALCOA+, GAMP 5 and CSV or CSA expectations
• Bridge manufacturing stakeholders, quality and compliance teams, and technical teams
• Run workshops, demos and requirement walkthroughs with users from operators to leadership

• Strong experience in MES business and process analysis, with Apprentice Tempo knowledge
• Proven experience gathering requirements and writing functional requirements and user stories
• Experience with fit gap analysis across MES, LIMS and SAP or ERP
• Strong understanding of manufacturing workflows in a regulated environment
• Experience with testing, UAT, validation and defect resolution
• Working knowledge of GxP, GMP, 21 CFR Part 11, ALCOA+, GAMP 5 and CSV or CSA
• Bachelor’s degree in Engineering, Computer Science, Life Sciences or a related field, * Greenfield MES or facility implementation experience (strongly preferred)
• Experience with Jira and Confluence for requirements and defect tracking
• Exposure to warehouse and lab processes such as cycle counts, receiving, sampling and chain of custody
• Knowledge of SAP MM, PP or QM and LIMS platforms such as LabWare or LabVantage
• Agile or Scrum experience

Ideal Candidate An MES Business Analyst with strong Apprentice Tempo knowledge who can bridge manufacturing stakeholders, compliance and technical teams