Senior Validation Engineer

Smart IT Frame LLC; California; On-site; USD 110,000 - 170,000; Full time

Job summary

Smart IT Frame LLC in California is seeking a Validation Engineer to lead testing and validation of laboratory instrument integrations across Analytical Development and Quality Control. You will drive data pipelines and ensure ALCOA+ data integrity while supporting GxP release cycles and 21 CFR Part 11 compliance.

You will collaborate with cross-functional teams, write validation protocols, and manage defect lifecycles in a global delivery environment.

Qualifications

• Proven experience in lab informatics test projects in pharma/biotech environments.
• Hands-on data integration testing across APIs, data flows and schemas (JSON/XML).
• Strong knowledge of GxP, CSV, and validation of regulated software.
• Experience with test management and agile delivery (HP ALM, Jira).
• Awareness of test automation opportunities to reduce manual testing.
• Knowledge of pharmaceutical or CGT supply chain processes is a plus.
• Ability to develop and execute test plans and scripts for validated apps.

Responsibilities

• Lead testing of instrument-to-cloud integrations via CGTs platforms.
• Write and execute validation protocols (IQ/OQ/PQ equivalents for software).
• Ensure data integrity and ALCOA+ adherence across systems.
• Collaborate with analytics, engineering, and IT teams in a global setting.
• Manage defect lifecycles and communicate complex issues to stakeholders.

Skills

Lab Informatics Experience

Data Integration Testing

GxP & CSV Expertise

Testing Tools & Agile Delivery

Automation Awareness

Pharma/CGT knowledge

Test plan/test scripts development

Tools

HP ALM

Jira

Agile (Scrum/Kanban)

Job description

Job Position: Validation Engineer

Job type: C2C/W2

Experience Required: 12+ & Above

Duration:12+month

Role Descriptions:

: 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

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
• 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
• 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.