Validation Tester (CoreAI PTC)

Job Title – Validation Tester (CoreAI PTC)

Location: San Francisco, CA

About Roche – CoreAI PTC

We drive and realize Cell and Gene Therapies (CGT) by translating scientific progress into life-changing experiences for patients.

Our key strengths include:

• Global reputation for industry-leading contributions.
• Cell and Gene Therapy powerhouse at Roche.
• Driver of life-changing treatments for patients.
• Talent destination and incubator.
• Partner of choice and pioneer in a new era of 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.

In this role, you will test complex data pipelines on the Tetra Platform, ensuring seamless data flow from benchtop instruments to enterprise systems such as LIMS and Data Lakes.

By ensuring data integrity and system reliability, you will directly support the rapid development and GxP release of life-saving Cell and Gene Therapies (CGT).

Key Responsibilities

1. Testing and Validation
• Design and execute comprehensive test strategies, test plans, test scripts, and edge-case scenarios for instrument-to-cloud integrations through the Tetra Platform.
• Test complex data pipelines and laboratory instrument integrations.
• Verify accurate data parsing, mapping, and transfer across Level 2 (instruments) and Level 3 (LIMS/LES) system boundaries.
• Ensure compliance with ALCOA+ data integrity principles.
2. GxP Validation and Compliance
• Lead GxP validation activities and prepare validation protocols (IQ/OQ/PQ equivalents for software).
• Ensure digital pipelines comply with 21 CFR Part 11 and EU Annex 11 requirements.
• Demonstrate knowledge of current GxP requirements and documentation standards.
• Prepare and execute validation documents and test scripts for regulated applications.
3. Cross-Functional Collaboration
• Collaborate with business analysts, laboratory scientists, data engineers, and solution architects.
• Work effectively with global and cross-functional teams.
• Manage communications with multiple business units and internal IT teams.
4. Requirements and Documentation
• Gather and analyze business and technical requirements.
• Support functional design, system risk assessments, and data classification.
• Prepare reports and supplier assessments as required.
• Explain complex technical concepts clearly and effectively.
5. Defect Management
• Identify, document, track, and retest defects throughout the testing lifecycle.
• Communicate technical issues effectively to IT and business stakeholders.
• Proactively lead testing activities and ensure timely resolution of issues.

Candidate Requirements

1. Lab Informatics Experience

• Proven experience in testing laboratory systems such as LIMS, CDS, ELN, and SDMS.
• Understanding of analytical workflows within pharmaceutical R&D or Quality Control environments.

2. Data Integration Testing

• Hands-on experience testing APIs, data flows, and scientific data schemas such as JSON and XML.
• Familiarity with the Tetra Data Platform or similar scientific data cloud platforms is a major advantage.
• Understanding of instrument-to-enterprise system integrations.

3. GxP and Computer System Validation (CSV)

• Strong working knowledge of pharmaceutical validation and Computer System Validation (CSV).
• Experience executing test scripts for GxP-regulated and validated applications.
• Understanding of 21 CFR Part 11, Annex 11, and ALCOA+ principles.

4. Testing Tools and Agile Methodologies

• Proficiency in HP ALM and Jira.
• Experience working with Agile delivery methodologies, including Scrum and Kanban.
• Ability to develop test plans, test strategies, and detailed test scripts.

5. Test Automation Awareness

• Familiarity with test automation frameworks and processes.
• Ability to identify manual test cases that can potentially be automated in the future.

6. Additional Skills

• Knowledge of pharmaceutical and/or Cell and Gene Therapy supply chain processes is an advantage.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities.
• High attention to detail and accuracy.
• Ability to explain complex concepts in a clear and simple manner.
• Proactive approach with the ability to work independently and within global teams.