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 transfer, and other process validation related activities.
• Stay abreast of industry trends, regulatory updates, and technological advancements related to process validation in the cell and gene therapy field and propose continuous improvement initiatives to enhance validation processes and practices.
• Provide technical guidance and mentorship to junior team members, fostering a culture of knowledge sharing and professional development.
• Support Equipment, Facility, and Utility Commissioning and Qualification efforts, as necessary.

Qualifications:

• Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).
• Knowledge of validation principles across multiple disciplines, which may include process validation, aseptic process simulation, equipment qualification, and/or computer systems.
• Significant experience in process validation within the pharmaceutical or biotechnology industry.
• Strong understanding of Quality by Design (QbD) principles with proficiency in risk assessment methodologies (e.g., PFMEA) and statistical analysis tools for validation data (e.g., Minitab, JMP).
• Strong understanding of cGMPs (current Good Manufacturing Practices).
• Excellent analytical, problem-solving, and decision-making skills, with meticulous attention to detail.
• Effective communication and collaboration abilities, with the capacity to work cross-functionally and influence stakeholders at various levels of the organization.
• Strong project management skills, with the ability to prioritize and manage multiple validation projects concurrently.
• Experience in the application of commercial cGMPs.
• Experience with aseptic processing and clean room standards.
• Ability to work onsite (Columbus, Ohio) 4-5 days/week on average.

Preferred:

• Process Validation experience in the Cell & Gene Therapy Industry.
• Experience in qualifying a wide range of equipment, including Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, centrifuges, and analytical instruments.
• Experience in the application of pre-clinical and clinical cGMPs.
• Experience with Cleaning Validation.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.  

Work Environment and Physical Demands   

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Must be able to lift heavy objects up to 50 lbs. 

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  

We’ve Got You Covered:  

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:  

Health from day one 

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.  

Time to recharge 

• A competitive paid time off plan – because rest fuels innovation.  
• 12 weeks of fully paid parental leave so you can focus on family when it matters most.  

Rewarding your impact 

• Annual bonus opportunities for all full-time team members.  
• 401(k) with company match to help you plan for the future.  
• Special employee discounts, including childcare and dependent care savings.  

Your wellness, supported 

• Onsite fitness facility at The Hearth. 
• Mental health counseling and financial planning services through our Employee Assistance Program.  
• Employer-paid short and long-term disability coverage to protect your peace of mind.  

Fuel for your workday 

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.  

Grow with us 

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.