CSV Consultant

Katalyst CRO; Raritan (NJ); On-site; USD 85,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a qualified professional for validation programs within the pharma/biotech/medical device space in New Jersey. The role emphasizes CSV, SDLC, GxP, and risk-based validation in FDA/global environments, with strong documentation skills and cross-functional collaboration.

The ideal candidate has 3+ years in CSV and 2+ years in SDLC, with exposure to QA methodologies, test plans, UAT, and traceability matrices. Remote collaboration is supported across projects.

Qualifications

• Experience in the Pharma/biotech/medical device industry.
• 2+ years' experience with the System Development Lifecycle (SDLC).
• 3+ years' experience in Computer System Validation (CSV).
• Experience in FDA/global regulated environments with GxP and risk-based validation.
• Knowledge of FDA guidance and industry standards such as GAMP.
• Experience in writing and executing validation documentation (requirements, plans, test protocols, test summaries, validation reports).
• Experience reviewing system test, UAT scripts, traceability matrices, and design specs.
• Experience in QA methodologies and in designing/approving test plans and procedures; strong communication.
• Ability to work in a team or lead teams, including remote collaboration across multiple projects.

Skills

Pharma/biotech/med device

SDLC experience

CSV expertise

GxP knowledge

FDA guidance knowledge

GAMP knowledge

Validation documentation

Test plans & UAT

Traceability matrices

QA methodologies

Team leadership / collaboration

Remote teamwork

Strong communication

Job description

• Experience in the Pharmaceutical, biotechnology, or medical device industry.
• 2+ years' experience with System Development Lifecyle.
• 3+ years' experience in Computer System Validation (Based on the role selected).
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance's and industry standards (i.e., GAMP).
• 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, systems and 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.