Validation Engineer I

Job description

**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:** As a **Validation Engineer I**, you will be responsible for the design, implementation, and execution of equipment 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 equipment validation, and ensure adherence to regulatory requirements. **Responsibilities:** - Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience). - Experience in equipment validation within a regulated industry. - Experience in qualifying a wide range of equipment, including Isolators, Filling & Capping equipment, Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, and centrifuges. - Understanding of aseptic processing and clean room standards. - Proficiency in risk assessment methodologies. - 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. - Ability to work in a cleanroom environment while wearing appropriate gowning and PPE up to 50% of the time. **Qualifications:** - Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience). - Experience in equipment validation within the pharmaceutical or biotechnology industry. - Experience in qualifying a wide range of equipment, including Isolators, Filling & Capping equipment, Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, and centrifuges. - Experience with aseptic processing and clean room standards. - Proficiency in risk assessment methodologies. - 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. - Ability to work in a cleanroom environment while wearing appropriate gowning and PPE up to 50% of the time. **Preferred Skills:** - Experience in the Cell & Gene Therapy Industry. - Knowledge of validation principles across multiple disciplines, which may include computerized systems, aseptic process simulation, and/or process validation. - Experience in the application of pre-clinical, clinical, and commercial cGMPs. *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 is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments. 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.