Business Analyst (Manufacturing Domain)

Infinity Quest Limited; España; Remote; EUR 27,000 - 41,000; Full time

Job summary

Infinity Quest Limited is seeking a Senior Business Analyst in the Manufacturing domain to support an Enterprise Recipe Management initiative in a global pharmaceutical environment. The role requires collaboration with European and US teams, focusing on process analysis, requirements, and cross-system integrations.

The ideal candidate has 5–10 years of BA experience in regulated manufacturing, with fluency in English, and will contribute to defining Epics, User Stories, and functional specs

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering or related field.
• 5-10 years of experience as a Business Analyst or similar in pharmaceutical or regulated manufacturing.
• Strong knowledge of pharmaceutical manufacturing processes and recipe management.
• Experience with system integrations across MES, LIMS, ERP, PLM, ELN, and related platforms.

Responsibilities

• Engage with stakeholders and domain leads to identify opportunities and assess value, feasibility, complexity, and dependencies.
• Analyze end-to-end pharma manufacturing processes across systems and functions.
• Design and document epics, user stories, acceptance criteria, and functional specs.
• Work with Enterprise Recipe Management / PKM and related manufacturing systems.
• Analyze integrations across MES, LIMS, ERP, PLM, ELN, and other platforms.
• Define requirements for data flows, reporting, interoperability, ensuring GxP compliance.
• Create and maintain functional specs, ADRs, and technical documentation.
• Facilitate workshops to align business and technical teams on processes, data flows, and system capabilities.
• Identify opportunities to apply Generative AI/ML and evaluate relevant use cases.
• Collaborate with project teams to ensure clear understanding and delivery of requirements.
• Identify risks, dependencies, gaps, and opportunities across domains.
• Manage stakeholder discussions and drive toward actionable outcomes.

Skills

Business Analysis

Stakeholder Management

Regulated Manufacturing

Cross-System Integration

Requirements Gathering

Workflow Modeling

Education

Bachelor’s degree in Computer Science, Information Systems, Engineering

Tools

MES

LIMS

ERP SAP S/4HANA

PLM

ELN

DeltaV

Job description

Role: Senior Business Analyst (Manufacturing Domain)

Location: Poland

Mode: Remote

Type: Permanent

Job Description:

Overview

We are seeking a Senior Business Analyst – Manufacturing to support an Enterprise Recipe Management initiative within a global 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

• 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
• 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.