CSV Engineer I

Forge Biologics is seeking a CSV Engineer I to ensure GxP computerized systems are validated in compliance with regulatory standards, supporting gene therapy manufacturing operations.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field
• 2+ years of experience in Computer System Validation (CSV) within a GxP regulated environment
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+)
• Ability to work onsite (in Columbus, Ohio) 3-4 days/week on average

Benefits

• Health insurance
• Paid time off
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Special employee discounts
• Onsite fitness facility
• Mental health counseling and financial planning services
• Employer-paid short and long-term disability coverage