Role: Senior Business Analyst (Manufacturing Domain)

Location: Spain

Mode: Remote

Type: Permanent

Overview

We are seeking a Senior Business Analyst – Manufacturing to support an Enterprise Recipe Management initiative within a general pharmaceutical manufacturing environment.

The successful candidate will act as a Pharma Manufacturing Domain Expert , working closely with business stakeholders, domain leads, system owners, and technical teams to identify high-value business opportunities, assess feasibility, define requirements, and translate business needs into actionable solutions.

This role requires a strong understanding of pharmaceutical manufacturing processes, recipe management, system integration, and regulated/GxP environments . The candidate will be responsible for analyzing cross-system business processes, identifying improvement opportunities, and creating detailed Epics, User Stories, functional specifications, and technical documentation .

General Information

- Location/Time Zone: CET or NALA time zone
- Collaboration Hours: Must be available during 3:00–7:00 PM CET to support collaboration between European and US teams
- Work Model: Remote or Hybrid
- Travel: No regular travel expected

Key Responsibilities
- Engage with business stakeholders, system owners, and domain leads to identify business opportunities and assess their value, feasibility, complexity, and dependencies to support business case development.
- Analyze and document end-to-end pharmaceutical manufacturing processes across multiple systems and business functions.
- Design and document business process flows, requirements, Epics, User Stories, acceptance criteria ,



and functional specifications.
- Work with Enterprise Recipe Management / PKM solutions and related manufacturing systems.
- Analyze integrations across MES, LIMS, ERP, PLM, ELN, and other manufacturing platforms .
- Define requirements for system integrations, data flows, reporting, and interoperability while ensuring alignment with GxP and regulatory requirements .
- Create and maintain functional specifications, architecture decision records (ADRs), process documentation, and technical documentation .
- Facilitate workshops and discussions between business stakeholders and technical teams to establish a common understanding of:
- Business processes
- Data flows
- System capabilities
- Integration requirements
- Architectural decisions
- Identify opportunities to improve manufacturing processes through Generative AI/ML and support the evaluation and implementation of relevant use cases.
- Work closely with project and delivery teams to ensure requirements are clearly understood and successfully delivered.
- Proactively identify risks, dependencies, gaps, and opportunities across business and technical domains.
- Effectively manage stakeholder discussions, de-escalate conflicts, and maintain a strong focus on business outcomes.





Required Qualifications Must-Have
- Bachelor’s degree in Computer Science, Information Systems, Engineering , or a related discipline; equivalent practical experience may also be considered.
- 5–10 years of experience as a Business Analyst, Functional Architect, Functional Consultant, or similar role within Pharmaceutical, Life Sciences, or regulated manufacturing environments.
- Strong understanding of pharmaceutical manufacturing processes for drug substances and/or drug products.
- Hands-on experience with product recipe design, recipe management, and parameter definition within manufacturing systems such as MES, PLM, LIMS, ERP, or related platforms.
- Proven experience working on system integration projects involving platforms such as:
- MES
- LIMS
- ERP / SAP S/4HANA
- PLM
- ELN
- DeltaV or similar manufacturing control systems
- Strong understanding of cross-system business processes, data flows, integrations, and interoperability .
- Ability to translate complex business requirements into clear functional and non-functional requirements, Epics, User Stories, and acceptance criteria .
- Strong analytical and problem-solving skills.
- Excellent communication, facilitation, and stakeholder-management skills.
- Experience working collaboratively with global, cross-functional business and technology teams .
- Ability to manage challenging stakeholder discussions, de-escalate conflicts, and drive discussions toward actionable outcomes.
- Availability to work during 3:00–7:00 PM CET for EU/US collaboration.
- Fluent English , both written and spoken.

📌 Business Analyst (Manufacturing Domain) (España)
🏢 Infinity Quest
📍 España