Sr. Validation Engineer

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.   

About The Role

We are currently looking for a highly skilled and experienced Validation Engineer to join the Forge Biologics team. As a Senior Validation Engineer, 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.

What You'll Do

• Develop and execute equipment validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing equipment.
• Define acceptance criteria and develop test methods for equipment qualification, ensuring alignment with regulatory guidelines (FDA, EMA, etc.) and industry best practices.
• Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs, to ensure effective planning, execution, and completion of equipment validation activities.
• Lead and participate in investigations related to equipment validation deviations, non-conformances, and out-of-specification results, implementing appropriate corrective and preventive actions (CAPAs) as needed.
• Conduct hands-on validation activities, such as protocol generation, execution, data analysis, and report writing, ensuring compliance with regulatory requirements and internal quality standards.
• Stay abreast of industry trends, regulatory updates, and technological advancements related to equipment 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 validation engineers and other team members, fostering a culture of knowledge sharing and professional development.

What You'll Bring

• 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 computerized systems, cleaning, aseptic process simulation, and/or process validation.
• Significant experience in equipment validation within the pharmaceutical or biotechnology industry.
• Proficiency in risk assessment methodologies (e.g., FMEA, FMECA) and statistical analysis tools for validation data (e.g., Minitab, JMP).
• Strong understanding of GMPs (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.

Preferred Skills

• Equipment 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-cl