Validation Engineer

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

Job Description

The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. Specialist will be involved as the QA CSV representative during small and large-scale projects.

Job Description

The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. Specialist will be involved as the QA CSV representative during small and large-scale projects.

Responsibilities

• Perform all aspects of QMS process' - Change Control, Deviations, CAPAs.
• Execute all responsibilities as CSV project lead for complex projects.
• Oversee all CSV lifecycle activities.
• Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives.
• Mentor junior specialists.
• Revise and maintain CSV SOPs.
• Assess departments standing in the business and regulatory aspects.
• Function as CSV SME in Inspections and Audits.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree (Computer Science / Software Engineering).
• Advanced - 5-10 years.
• 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.