CSV Specialist

Katalyst-Healthcares-; Raritan (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC in the United States is seeking a Senior Validation Specialist with a minimum of 5 years of CSV experience to join our QA team in NJ. The role supports validation of GxP GenAI-based solutions and regulated environments, including FDA/global standards.

Responsibilities include writing and executing validation deliverables, reviewing test scripts and traceability matrices, and providing guidance to management.

Qualifications

• Minimum 5 years of CSV experience in a regulated setting.
• 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.
• Familiarity with FDA and Global regulated environments and GxP standards.
• Experience writing and executing validation documentation (requirements, validation plans, test protocols, reports).
• Experience reviewing system/test scripts, traceability matrices, and design specs.
• Experience in QA methodologies, designing and approving test plans and procedures.
• Strong verbal and written communication skills.
• Ability to work as a team, lead a team, or work independently.
• Ability to work with remote teams and manage multiple projects.

Skills

CSV experience

GxP validation

Regulated environment knowledge

Documentation writing

Test planning & execution

QA methodologies

Leadership

Remote collaboration

Risk-based validation

Job description

Requirements:

• Min 5 years of CSV experience.
• 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.