Senior Validation Engineer

About Forge Biologics

Forge Biologics turns bold ideas into life‑changing gene therapies. Our mission is to enable access to these therapies and bring them from concept into reality. We partner with scientists, physicians, biopharma innovators, and patient communities to improve 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. You’ll play a key role in bringing hope to patients with genetic diseases by scaling AAV manufacturing, collaborating on cutting‑edge therapies, or supporting complex technical projects. We live by H.O.P.E: hardworking, open, purpose‑driven, and engaged.

We are looking for a highly skilled Senior Validation Engineer I to join our team. The engineer will design, implement, and execute process validation activities ensuring compliance, quality, and efficacy of our manufacturing processes. The role works closely with cross‑functional teams to develop validation strategies and provide technical expertise in process validation and aseptic process simulation.

• Develop, implement, and maintain PPQ and CPV programs, including procedures, templates, and documentation.
• Lead execution of PPQ protocols for GMP manufacturing processes.
• Maintain and continuously improve the APS (Media Fill) program.
• Lead execution of new aseptic protocols for aseptic manufacturing processes.
• Collaborate with Process & Analytical Development, GMP Manufacturing, Operations, MSAT, Quality Management, QC, and Regulatory Affairs to plan, execute, and complete validation activities.
• Define sampling plans, test methods, and acceptance criteria for validation deliverables aligned with FDA, EMA, and internal procedures.
• Lead and participate in investigations related to validation deviations, implementing CAPAs as needed.
• Assess proposed process changes and develop validation plans.
• 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 validation related activities.
• Stay abreast of industry trends, regulatory updates, and technological advancements in process validation and propose continuous improvement initiatives.
• Provide technical guidance and mentorship to junior team members, fostering knowledge sharing and professional development.
• Support Equipment, Facility, and Utility Commissioning and Qualification efforts as necessary.

• Bachelor’s or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).
• Knowledge of validation principles across multiple disciplines including 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 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.
• 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.
• Strong project management skills, with the ability to prioritize and manage multiple validation projects concurrently.
• Experience with commercial cGMPs and aseptic processing and clean‑room standards.
• Ability to work onsite (Columbus, Ohio) 4–5 days/week on average.

• Process validation experience in the Cell & Gene Therapy industry.
• Experience qualifying a wide range of equipment including BSCs, CTUs, bioreactors, incubators, chromatography systems, centrifuges, and analytical instruments.
• Experience with pre‑clinical and clinical cGMPs.
• Experience with cleaning validation.

This position works in both a laboratory environment and typical office environment.…