Senior Validation Engineer I

Forge Your Future with Us

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins. 

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen — you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases. 

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together. 

At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us. 

If you're ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. 

About the Role:

We are currently looking for a highly skilled and experienced Senior Validation Engineer I to join the Forge Biologics team. As a Sr. Validation Engineer I, you will be responsible for the design, implementation, and execution of process validation activities to ensure the compliance, quality, and efficacy of our manufacturing processes. You will work closely with cross-functional teams to develop and execute validation strategies, provide technical expertise in process validation and aseptic process simulation to ensure adherence to regulatory compliance and industry best practices.

Responsibilities:

• Develop, Implement, and Maintain the Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs, including development of related procedures, templates, work instructions, and associated documentation.
• Develop and lead execution of Process Performance Qualification (PPQ) protocols, for GMP manufacturing processes.
• Maintain and provide continuous improvement of the Aseptic Process Simulation (APS) (Media Fill) program.
• Develop and lead execution of new aseptic (APS) protocols, for aseptic manufacturing processes.
• Collaborate with cross-functional teams, including Process & Analytical Development, GMP Manufacturing, Operations , Manufacturing Science and Technology (MSAT), Quality Management, Quality Control, and Regulatory Affairs to ensure effective planning, execution, and completion of validation activities.
• Define sampling plans and, test methods, and acceptance criteria for validation deliverables, ensuring alignment with regulatory guidelines (FDA, EMA, etc.), industry best practices, and internal procedures.
• Lead and participate in investigations related to validation deviations, implementing appropriate corrective and preventive actions (CAPAs) as needed.
• Assess changes to proposed process changes and develop validation plans, as necessary.
• Conduct hands-on validation activities, such as protocol generation, execution, data analysis, and report writing.
• Collaborate on risk management, process development studies, technology