MES Business Analyst (Manufacturing Execution Systems)

Location: Remote
Experience: 6-8 Years

We are seeking an experienced MES Business Analyst to support the implementation of the OSCAR Manufacturing Execution System (MES) for Electronic Batch Records (EBR) and equipment integration within a Life Sciences manufacturing environment. The ideal candidate will have strong expertise in business analysis MES functional consulting Agile methodologies requirements gathering UAT and stakeholder management with experience supporting manufacturing operations and digital transformation initiatives.

• Business Analysis
• Requirements Gathering
• Business Process Analysis
• Functional Requirements Documentation
• Business Requirements Documentation (BRD)
• Functional Requirements Documentation (FRD)
• User Stories
• Acceptance Criteria
• Process Mapping
• Gap Analysis
• Stakeholder Management
• Workshop Facilitation

• Manufacturing Execution Systems (MES)
• MES Functional Consulting
• Electronic Batch Records (EBR)
• Manufacturing Operations
• Equipment Integration
• Shop Floor Systems
• Process Automation
• Production Execution
• Manufacturing Process Improvement

• Agile Methodology
• Scrum
• SDLC
• Sprint Planning
• Backlog Grooming
• Jira
• Confluence
• Project Management

• Microsoft Excel
• SQL
• Power BI
• Data Analysis
• Reporting
• Dashboard Development
• Business Intelligence

• User Acceptance Testing (UAT)
• Test Planning
• Test Case Development
• Defect Management
• Business Validation
• End User Training

• Life Sciences
• Pharmaceutical Manufacturing
• GxP Compliance
• GMP
• FDA-Regulated Environments
• Electronic Batch Records (EBR)
• Audit Readiness

• Analytical Thinking
• Problem Solving
• Communication Skills
• Cross-functional Collaboration
• Customer Focus
• Organizational Skills
• Time Management
• Documentation

• Partner with Manufacturing Operations to deliver business value through MES implementation new product introductions and process improvements.
• Gather analyze and document business and functional requirements for the OSCAR MES implementation.
• Collaborate with business stakeholders IT teams and manufacturing sites to translate business needs into scalable MES solutions.
• Create and maintain user stories process flows functional specifications and acceptance criteria.
• Facilitate workshops stakeholder meetings and requirement-gathering sessions.
• Support the implementation of Electronic Batch Records (EBR) and equipment integration within the MES platform.
• Coordinate and support User Acceptance Testing (UAT) defect resolution and end-user training activities.
• Utilize Jira and Confluence to manage project requirements documentation and Agile workflows.
• Perform data analysis and reporting using Excel SQL and Power BI to support business decision-making.
• Ensure solutions comply with GxP GMP and Life Sciences regulatory requirements.
• Collaborate with cross-functional teams to drive continuous process improvements and successful solution delivery.

• Experience implementing or supporting OSCAR MES Werum PAS-X Siemens Opcenter Rockwell PharmaSuite Syncade or similar MES platforms.
• Experience with Electronic Batch Records (EBR) implementations.
• Experience in Pharmaceutical Biotechnology or Life Sciences manufacturing.
• Knowledge of GxP GMP FDA and regulated manufacturing environments.
• Bachelors degree in Business Administration Information Technology Engineering Computer Science Life Sciences or a related field.
• Experience working in Agile delivery environments.