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 Senior Validation Engineer to join the Forge Biologics team. As a Sr. Validation Engineer, 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.

What You'll Do

• 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.

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 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-so