Lead CSV Validation Engineer — GMP & Compliance

Katalyst CRO; Portsmouth (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a skilled CSV Specialist Level 4 to lead and train teams in assessing computer systems for compliance with company policies and industry guidance. You will risk assess systems, review change requests and test scripts, draft protocols and oversee GMP documentation revisions.

You will also serve as the QA CSV representative on projects of varying size. The role emphasizes leadership of CSV activities, collaboration with QA, and ensuring regulatory alignment across changes

Qualifications

• Bachelor's Degree in Computer Science or Software Engineering.
• Advanced - 5–10 years of experience.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
• Strong written and oral communication skills.
• Strong organizational and time management skills.

Responsibilities

• Perform all aspects of QMS processes: Change Control, Deviations, CAPAs.
• Lead CSV projects as project lead for complex initiatives.
• Oversee CSV lifecycle activities from planning to close.
• Schedule qualification activities to meet manufacturing and quality objectives.
• Mentor junior CSV specialists and share knowledge.
• Revise and maintain CSV SOPs to ensure compliance.
• Act as CSV SME during inspections and audits.
• Perform other duties as assigned.

Skills

Team leadership

Communication

Time management

Education

Bachelor's Degree in Computer Science / Software Engineering

Job description

Katalyst CRO is seeking a skilled CSV Specialist Level 4 to lead and train teams in assessing computer systems for compliance with company policies and industry guidance. You will risk assess systems, review change requests and test scripts, draft protocols and oversee GMP documentation revisions.

You will also serve as the QA CSV representative on projects of varying size. The role emphasizes leadership of CSV activities, collaboration with QA, and ensuring regulatory alignment across changes