Job Summary

We are looking for an experienced Business Analyst with strong expertise in LIMS or MES systems and deep exposure to the US pharmaceutical or drug manufacturing domain. The role involves working in GxP-regulated environments, supporting CSV initiatives, and acting as a bridge between business, quality, manufacturing, and IT teams.

Key Responsibilities

• Work as a Business Analyst supporting LIMS/MES/QMS/ERP systems in regulated pharma environments

• Gather, analyze, and document business and functional requirements including BRD, FRD, URS, FRS

• Elicit requirements through stakeholder interviews, workshops, and surveys

• Translate business needs into user stories, use cases, acceptance criteria, and process flows

• Perform fit-gap analysis against SAP and other enterprise platforms

• Map and analyze drug manufacturing processes including batch records, QC workflows, deviations, CAPA, and serialization

• Support CSV activities including URS/FRS, IQ/OQ/PQ, test scripts, and traceability matrices

• Collaborate with cross-functional teams including manufacturing, quality, regulatory, R&D, and digital health

• Create and maintain detailed documentation such as:

  • Business Requirements Document (BRD)

  • Functional Requirements Document (FRD)

  • User Requirement Specification (URS)

  • Traceability Matrix

  • User Stories & Acceptance Criteria

  • Process Flow Diagrams (BPMN, Swimlane)

  • Data Mapping and Field-Level Specifications

Required Skills & Experience

• 12+ years of overall experience as a Business Analyst

• Minimum 5+ years of experience in US pharmaceutical or drug manufacturing

• Strong knowledge of GxP environments, 21 CFR Part 11, and GAMP5 compliance

• Deep understanding of CSV methodologies

• Experience with Cell Therapy Life Cycle processes is a strong plus

• Hands-on experience with BPMN/UML process modeling

• Strong data analysis skills with SQL and Python

• Exposure to cloud platforms such as AWS, Azure, or GCP

Soft Skills

• Strong stakeholder management and communication skills

• Ability to translate complex technical concepts for non-technical audiences

• Strategic thinker with a data-driven mindset

• Comfortable working in fast-paced, Agile environments

• Passion for innovation and digital transformation

• Alignment with company values: speed, agility, and patient-centric innovation