Role Summary

We are seeking an experienced Business Analyst to join a Scrum team supporting a customer-facing

digital pipeline programme within a GxP-regulated pharmaceutical environment. The successful

candidate will act as the bridge between IT and a team of scientists supporting manufacturing

operations, responsible for gathering user requirements, leading user acceptance testing (UAT),

managing change and risk, and ensuring alignment with SDLC activities. This role requires strong

pharmaceutical industry experience, proven SDLC and Agile/Scrum expertise, and the ability to work

effectively with both technical IT teams and business stakeholders in a European-based, full-time

capacity (Monday–Friday)

Key Responsibilities

Partner with scientists and manufacturing support teams to elicit, document, and validate

User Requirements for digital pipeline solutions in GxP and non-GxP environments.

Lead end-to-end User Acceptance Testing (UAT) activities including test planning, script

development, environment readiness, defect logging, and closure in alignment with GxP

compliance standards.

Serve as the primary liaison between business stakeholders and the IT Scrum team (IT

Business Analysts, Data Analysts, Scrum Master, and Support) to ensure clear

communication and alignment on deliverables.

Align with IT and the Scrum Master on SDLC activities, ensuring all development, testing, and

deployment phases meet regulatory and quality requirements.

Support Change Management and Risk Management processes, including documentation,

impact assessments, and stakeholder communication.

Collaborate on User Story completion, ensuring requirements are translated into actionable,

testable specifications for the development team.

Map and interpret multivariate data to understand its application and determine optimal

presentation for model use, taking current market considerations into account.

Maintain controlled documentation including URS, functional specifications, test

protocols/reports, and validation artifacts aligned with GxP governance standards.

Communicate project progress, risks, and outcomes to stakeholders in a clear, timely manner.

Skills Required:

Essential (Must-Have):

Pharmaceutical industry experience with exposure to GxP-regulated environments (GMP,

GCP, GLP).

SDLC experience in regulated environments, including requirements, design, development,

testing, deployment, and maintenance phases.

Proven experience in User Requirements gathering and User Acceptance Testing (UAT)

within pharmaceutical or life sciences contexts.

Minimum 2–3 years of experience working in a Scrum team (Agile methodology),

collaborating with IT developers, data analysts, and Scrum Masters.

Bachelor's degree in Life Sciences, Pharmacy, Computer Science, Engineering, or a related

discipline.

Excellent stakeholder management, communication, and presentation skills with the ability to

work in a business-facing capacity.

Strong organisational, analytical, and problem-solving capabilities with attention to detail and

compliance.

Ability to work full-time (Monday–Friday) in a European time zone; ideally European-based.

Advantageous (Nice-to-Have):

Experience with PI Historian (OSIsoft) or similar process data historian platforms.

Knowledge of SIMCA and/or Multivariate Analysis (MVA) data concepts.

Experience with Dashboard/Power BI tools for data visualization and reporting.

Familiarity with Confluence or similar documentation and collaboration platforms.

Exposure to 21 CFR Part 11, CSV (Computer System Validation), and data integrity

standards