Senior Validation Engineer I

Forge Biologics is a biotechnology company that enables access to life-changing gene therapies. We are looking for a Senior Validation Engineer I to join our team and be responsible for designing, implementing, and executing process validation activities to ensure compliance, quality, and efficacy of our manufacturing processes.

Requirements

• Develop, Implement, and Maintain the Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs
• Develop and lead execution of Process Performance Qualification (PPQ) protocols
• Maintain and provide continuous improvement of the Aseptic Process Simulation (APS) (Media Fill) program
• Collaborate with cross-functional teams
• Define sampling plans and, test methods, and acceptance criteria for validation deliverables
• Lead and participate in investigations related to validation deviations
• Conduct hands-on validation activities

Benefits

• Health, dental and vision insurance
• Time to recharge (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
• Free snacks and beverages