| Job Description: |
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:
In Pharma Technical Operations (PT), Roche is advancing a cutting-edge
pipeline of Cell and Gene Therapies (CGT) to bring transformative treatments
to patients. Scaling these complex, individualized modalities from early
technical development into commercial manufacturing demands a robust,
automated digital ecosystem.
As the Validation Lead for CoreAI Lab Instrument Integration, you will
direct the Computer Systems Validation (CSV) and Computer Software
Assurance (CSA) strategy for integrating analytical and quality control
laboratory instruments into the Tetra Data Platform (TDP). You will bridge
the gap between fast-paced experimentation in Analytical Development
(AD-non GxP) and strict GxP compliance in Quality Control (QC). Working
directly with instrument specialists, data engineers, automation architects,
and QA SMEs, you will ensure our automated data acquisition pipelines
safeguard data integrity, satisfy 21 CFR Part 11 standards, and accelerate
release-by-exception for life-saving cell therapies.
Responsibilities: ● Validation Strategy & Governance: Formulate and execute a validation
strategy for laboratory instrument integration via the Tetra Data
Platform, ensuring alignment with GAMP 5, Roche Quality Management
Standards, and global health authority regulations (FDA, EMA,
Swissmedic).
● Pipeline & Interface Qualification: Author and execute validation
master plans (VMP), user requirements specifications (URS), risk
assessments, and qualification protocols (IQ/OQ/PQ) for Tetra Data
Hubs, Tetra Agents, cloud connectors, and raw-to-IDS (Intermediate Data
Schema) parsing pipelines.
● Data Integrity & Compliance Architecture: Enforce ALCOA+ data
integrity principles and 21 CFR Part 11 / EU Annex 11 compliance across
all instrument data streams. Qualify automated audit trail capture,
electronic signatures, and bidirectional metadata flows between
instruments and Level 3 systems (LIMS, ELN, LES).
● Risk-Based Testing & Test Automation: Lead end-to-end verification
and boundary testing alongside dedicated testers and QA. Drive the
adoption of automated test scripts within CI/CD pipelines to validate
data ingestion schemas and reduce manual regression testing.
● Stakeholder & Vendor Alignment: Collaborate closely with Analytical
Development scientists, QC lab leads, IT/OT engineers, and cloud
platform architects to define scope and acceptance criteria. Partner with
vendors (TetraScience, analytical instrument Original Equipment
Manufacturers) to review vendor documentation and establish supplier
quality assessments.
● Lifecycle & Change Management: Manage the validation lifecycle
through operational changes, patch releases, schema upgrades, and new
instrument onboarding, maintaining a continuous state of control and
inspection-readiness.
Candidate
requirements: ● Analytical Instrument & Platform Knowledge: Experience validating
laboratory instrument interfaces (e.g., flow cytometers, automated cell
counters, ddPCR, SPR/Biacore, HPLC/UPLC) and modern scientific cloud
data platforms (specifically TetraScience / Tetra Data Platform).
● Regulatory & Framework Mastery: Knowledge of GAMP 5, FDA 21 CFR
Part 11, EU Annex 11, and PIC/S data integrity guidance.
● Validation Documentation: Strong track record authoring clear,
audit-ready validation deliverables (Traceability Matrices, Risk
Assessments, Test Protocols, Validation Summary Reports) in electronic
quality tools (e.g., ServiceNow, HP ALM, or Jira).
● Direct experience in Cell and Gene Therapy (CGT) technical operations
is a plus
● Familiarity with Roche internal CSV frameworks and Quality
Management System processes is a plus.
● Knowledge of pharma and/or cell & gene therapy supply chain processes
is a plus.
● Demonstrates ability to perform detail-oriented work with a high degree
of accuracy and able to explain complex concepts with clarity and
simplicity.
● Demonstrates ability to identify, troubleshoot and resolve issues quickly
and effectively.
● Positive attitude and high energy with exceptional cross-group
collaboration working with partner teams
● Possess a combination of analytical thinking, hands-on problem-solving,
and a customer-service mindset
● Experience in ServiceNow and AWS technologies
● Excellent communication skills - fluent in written and spoken english.
● Language - English / Travel Requirement - 20% (as needed)
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