Senior GxP Validation Tester – CoreAI / Laboratory Data Integration

 

 

 

We drive and realise cell and gene therapies by translating scientific
progress into life-changing experiences for patients.
❖ Global Reputation for industry-leading contributions
❖ Cell and Gene Therapy powerhouse at Roche
❖ Driver of life-changing treatment for patients
❖ Talent destination and incubator
❖ Partner of choice and Pioneer in a new era in medicine
About the role:
Join the CoreAI delivery squad to drive the testing and validation of
laboratory instrument integrations across Analytical Development and
Quality Control. You will test complex data pipelines on the Tetra
Platform, ensuring seamless data flow from benchtop instruments to our
enterprise systems (e.g., LIMS, Data Lakes). By ensuring absolute data
integrity and system reliability, you will directly support the rapid
development and GxP release of life-saving Cell & Gene Therapies (CGT).
Responsibilities: Demonstrate ability to perform detail-oriented work with a high degree
of accuracy and able to explain complex concepts with clarity and
simplicity.
Ability to proactively lead the testing effort and work in a
cross-functional and global team.
Demonstrate knowledge of current GxP requirements and
documentation standards, with the ability to write validation docs.
Managing communications with multiple business units as well as
internal IT cross-functional teams.
Requirements gathering, synthesis, functional design, system risk
assessments, data classifications, report, supplier assessment as
required.
Design and Execute Test Strategies: Author and execute
comprehensive test plans, scripts, and edge-case scenarios for
instrument-to-cloud integrations via the Tetra Platform.
Validate Data Integrity: Verify accurate data parsing, mapping, and
transfer across Level 2 (instruments) and Level 3 (LIMS/LES) system
boundaries, strictly adhering to ALCOA+ principles.
Lead GxP Validation Efforts: Draft and execute validation protocols
(IQ/OQ/PQ equivalents for software) to ensure our digital pipelines
meet 21 CFR Part 11 and Annex 11 requirements.
Collaborate Cross-Functionally: Partner closely with business analysts,
lab scientists, data engineers, and solution architects.
Manage Defect Lifecycles: Identify, log, and re-test defects, clearly
communicating complex technical pipeline issues to both IT and
business stakeholders.
Candidate
requirements:
● Lab Informatics Experience: Proven experience testing laboratory
systems (e.g., LIMS, CDS, ELN, SDMS) and understanding analytical
workflows in pharmaceutical R&D or QC environments.
● Data Integration Testing: Hands-on experience testing APIs, data
flows, and scientific data schemas (e.g., JSON, XML). Familiarity with
the Tetra Data Platform or similar scientific data clouds is a major
plus.
● GxP & CSV Expertise: Strong working knowledge of pharmaceutical
validation, Computer System Validation (CSV), and executing test
scripts for strictly regulated applications.
● Testing Tools & Agile Delivery: Proficiency with HP ALM, Jira, and
Agile (Scrum/Kanban) delivery methodologies.
● Automation Awareness: Familiarity with test automation
frameworks and processes to help the team identify manual tests
that we can automate in the future.
● Knowledge of pharma and/or cell & gene therapy supply chain
processes is a plus.
● Ability to develop test plan/test scripts, and experience in executing
test scripts for GxP/validated applications.
● Good communication skills.
● Language - English / Travel Requirement - 20% (as needed)