Description

Key Responsibilities

Business Analysis

•              Partner with Manufacturing Operations to identify business needs, process improvements, and productivity opportunities.

•              Gather, analyze, validate, and document complex business and functional requirements.

•              Translate business requirements into detailed functional specifications and technical requirements.

•              Analyze current manufacturing processes and recommend optimized future-state solutions.

MES Implementation

•              Support the implementation and enhancement of OSCAR Manufacturing Execution System (MES).

•              Participate in Electronic Batch Record (EBR) implementation activities.

•              Support Equipment Integration and OCPLM integration initiatives.

•              Develop expertise in MES workflows and manufacturing execution processes.

Agile Delivery

•              Participate in Agile ceremonies including Sprint Planning, Daily Stand-ups, Backlog Grooming, Sprint Reviews, and Retrospectives.

•              Create and manage:

•              User Stories

•              Acceptance Criteria

•              Business Requirements Documents (BRDs)

•              Functional Specifications

•              Process Flow Diagrams

•              Epics and Features

•              Collaborate closely with Product Owners, Developers, QA, Validation, and Business Stakeholders.

Stakeholder Management

•              Lead business workshops and requirements elicitation sessions.

•              Facilitate communication between Manufacturing Operations and IT teams.

•              Manage stakeholder expectations and resolve business process challenges.

•              Present project updates, risks, and recommendations to leadership.

Testing & Training

•              Lead User Acceptance Testing (UAT) activities.

•              Develop test scenarios, test scripts, and traceability matrices.

•              Coordinate defect resolution with development teams.

•              Support end-user training, adoption, and change management initiatives.

Documentation

•              Maintain project documentation using JIRA and Confluence.

•              Develop process maps, workflow diagrams, and functional documentation.

•              Ensure compliance with SDLC, validation, and documentation standards.

Required Qualifications

•              Bachelor's Degree in:

•              Business Administration

•              Computer Science

•              Information Technology

•              Engineering

•              Life Sciences

•              or a related discipline

•              5+ years of experience in Business Analysis, Requirements Management, Process Improvement, and IT Solution Delivery.

Required Skills & Experience

Candidates should possess 5+ years of hands-on experience in the following areas:

•              Business Analysis

•              Business Requirements Gathering and Analysis

•              Functional and Technical Requirements Documentation

•              Business Process Analysis and Improvement

•              Gap Analysis

•              Process Mapping (Current-State/Future-State)

•              Requirements Traceability

•              User Story Creation

•              Acceptance Criteria Definition

•              Business Case Development

Agile & Project Delivery

•              Agile (Scrum/Kanban) methodologies

•              Software Development Life Cycle (SDLC)

•              Sprint Planning and Backlog Refinement

•              Release Planning

•              Requirements Prioritization

•              Cross-functional Agile team collaboration

Data Analysis & Reporting

•              Advanced Microsoft Excel

•              SQL

•              Power BI

•              Data Analysis and Visualization

•              KPI and Operational Reporting

Project & Documentation Tools

•              JIRA

•              Confluence

•              Microsoft Office Suite

•              Visio or similar process mapping tools

•              Project documentation and collaboration platforms

Testing & Validation

•              User Acceptance Testing (UAT)

•              Test Planning

•              Test Script Development

•              Defect Tracking and Resolution

•              Validation support within regulated environments

Stakeholder Management

•              Workshop Facilitation

•              Executive and Business Communication

•              Cross-functional Team Collaboration

•              Requirements Prioritization

•              Conflict Resolution

•              Change Management

Preferred Qualifications

•              5+ years of experience supporting or implementing Manufacturing Execution Systems (MES).

•              1 to 3 years of experience with Electronic Batch Records (EBR).

•              3+ years of experience with Equipment Integration and manufacturing automation.

•              3+ years of experience working in Life Sciences, Pharmaceuticals, Biotechnology, or Medical Device industries.

•              Experience in GxP-regulated environments (FDA, GMP, 21 CFR Part 11).

•              Familiarity with software configuration and implementation projects.

•              Experience supporting manufacturing digital transformation initiatives.

Technical Competencies

•              Manufacturing Execution Systems (MES)

•              Electronic Batch Records (EBR)

•              Manufacturing Operations

•              Equipment Integration

•              OCPLM Integration

•              Process Automation

•              Digital Manufacturing

•              Business Process Improvement

•              Root Cause Analysis

•              Process Mapping

•              Workflow Documentation

•              Data Analytics

•              Regulatory Compliance (GxP, GMP)

Key Deliverables

•              Business Requirements Documents (BRDs)

•              Functional Requirements Specifications (FRS)

•              User Stories, Features, and Epics

•              Acceptance Criteria

•              Process Flow Diagrams

•              Current-State and Future-State Process Maps

•              Requirements Traceability Matrix (RTM)

•              UAT Plans, Test Scripts, and Results

•              Training Documentation

•              Workshop Artifacts

•              JIRA and Confluence Documentation

•              Stakeholder Communication Materials

Key Skills

Education

Bachelor's degree