Senior Business Analyst - Pharmaceutical Manufacturing

Capgemini • Burlington, MA

8d • Hybrid

About The Position

Join Capgemini as a Senior Business Analyst to drive business outcomes for a new initiative to enable compliant, high-quality experimentation. As a partner to product management, engineering, data, QA, compliance, and vendor teams, this role will translate complex scientific and operational needs into clear requirements, orchestrate end-to-end process and data design, and ensure value realization from a COTS/SaaS platform in a regulated environment. The ideal candidate brings deep business analysis expertise across life sciences/CMC workflows, strong experience with commercial platforms, and fluency working in SAFe/Agile-at-scale programs.LocationThis is a hybrid role located in Gaithersburg, MD. Remote work is permitted, with an in office requirement of 2-3 days per month.

Requirements

• 5+ years of documented experience in a business analyst or PMO role in pharmaceutical or life sciences organizations.
• Hands-on experience implementing or working with commercial (COTS/SaaS) platforms—ideally in laboratory, bioprocess, or experimentation domains.
• Demonstrated delivery within regulated environments with QA/compliance collaboration.
• Practical experience working in SAFe/Agile-at-scale programs
• Familiarity with validation, data integrity, and GxP considerations for SaaS/COTS implementations.
• Strong understanding of CMC/life sciences workflows and associated data/process needs.
• Excellent stakeholder management, facilitation, and communication skills.
• Is fully competent in its own area and has a deep understanding of related programming concepts software design and software development principles. Works autonomously with minimal supervision. Able to act as a key contributor in a complex environment, lead the activities of a team for software design and software development. Acts proactively to understand internalorexternal client needs and offers advice even when not asked. Able to assess and adapt to project issues, formulate innovative solutions, work under pressure and drive team to succeed against its technical and commercial goals. Aware of profitability needs and may manage costs for specific projectorwork area. Explains difficult concepts to a variety of audiences to ensure meaning is understood. Motivates other team members and creates informal networks with key contacts outside own area.

Responsibilities

• Partner with product/program management, engineering, data, QA, compliance, and vendor teams to gather and clarify business, scientific, and operational needs.
• Translate complex CMC/experimentation workflows into clear, testable functional and non-functional requirements and user stories.
• Define data models, interfaces, and information flows needed to enable compliant, high-quality experimentation.
• Lead/coordinate implementation of new COTS and SaaS solutions aligned to regulatory requirements. Configure capabilities, define integrations, and align platform features to business outcomes.
• Establish success metrics/KPIs and ensure value realization from the platform and workflows.
• Support backlog prioritization, release planning, and readiness (incl. change management and training inputs).
• Ensure processes and requirements align with applicable GxP/QA and data integrity expectations. Partner with QA/compliance to embed controls, auditability, and validation considerations.
• Leverage SAFe methodology and ceremonies (PI planning, backlog refinement, sprint reviews), and maintain high-quality artifacts (epics/features/stories, acceptance criteria) to support User Acceptance Testing.
• Coordinate with vendors on solution design, issues, and roadmap alignment. Communicate status, risks, and decisions to cross-functional stakeholders.
• Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutionsorapplications.
• Applies scientific methods to analyse and solve software engineering problems.
• Heorshe is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.
• Hisorher work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.
• The software engineer builds skills and expertise of hisorher software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.
• The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed