CSV Specialist

Katalyst CRO; Raritan (NJ); On-site; USD 120,000 - 165,000; Full time

Job summary

Katalyst CRO is seeking an experienced Validation Specialist to support GxP validation of GEN AI-based solutions within the pharmaceutical, biotech or medical device sectors. The role focuses on regulatory compliance in FDA/global environments and risk-based validation, with responsibilities for creating and reviewing validation deliverables.

You will review test scripts and design specs, maintain traceability, and provide guidance to project teams.

Qualifications

• Experience in validating GxP GEN AI-based solutions
• Experience supporting mergers/acquisitions/divestitures
• Experience in Pharmaceutical, biotechnology, or medical device industry
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
• Experience in writing and executing documentation for validation deliverables (requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs
• Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures
• Strong verbal and written communication skills
• Ability to work as a team player, lead a team or accomplish tasks without supervision
• Ability to work with remote teams and support several changes/projects simultaneously
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management

Skills

GxP validation

GenAI validation

Pharma/biotech/medical devices

FDA/regulatory

Documentation & validation delivera

Test scripts & traceability

QA methodologies

Communication skills

Team leadership / self-sufficiency

Remote collaboration

Validation guidance

Job description

• experience supporting validation of GxP GEN AI based solutions is a major plus
• experience supporting mergers/acquisitions/divestitures is a major plus
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
• Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.