Computer System Validation Specialist (12 month limited-term)

📋 Description

• Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR
• Develop and maintain validation documentation, including validation plans, test scripts
• Partner with IT, Quality Assurance, business stakeholders, and external vendors to define
• Coordinate and oversee validation testing activities, ensuring requirements are appropriately
• Manage defects, deviations, and incidents identified during testing, including triage, resolution
• Facilitate review, approval, execution, and post-execution management of validation and

🎯 Requirements

• Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development
• Experience validating GCP-regulated computerized systems and software, ideally within the
• Strong understanding of quality system principles, including validation, documentation, change
• Proven ability to collaborate effectively in cross-functional and matrixed environments, building
• Excellent written and verbal communication skills, with the ability to clearly document, present
• Experience working within Software Development Lifecycle (SDLC) processes; familiarity with

🎁 Benefits

• Education Reimbursement program for full-time employees
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office
• Working while visiting program – up to 4 weeks per year!
• Flexible Summer Hours Program from May – September
• Employee referral incentive – we know great people know other great people, and we think that