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Forge Biologics is seeking a Validation Engineer I to design, implement, and execute equipment validation activities for their cGMP manufacturing facility in Columbus, Ohio. The role focuses on ensuring compliance, quality, and efficacy of manufacturing processes for gene therapies and biologics.
Key responsibilities include developing and executing validation strategies for a wide range of equipment including isolators, filling and capping systems, biological safety cabinets, controlled temperature units, bioreactors, incubators, chromatography systems, and centrifuges. You will work cross-functionally with scientists, engineers, and quality teams to ensure adherence to regulatory requirements and cGMP standards.
The ideal candidate holds a Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field, with demonstrated experience in equipment validation within regulated pharmaceutical or biotechnology environments. Required competencies include proficiency in risk assessment methodologies, understanding of aseptic processing and cleanroom standards, strong project management skills, and the ability to manage multiple validation projects concurrently.
You will spend approximately 50% of your time in cleanroom environments wearing appropriate gowning and personal protective equipment. The role requires excellent analytical and problem-solving skills, meticulous attention to detail, and the ability to communicate effectively with stakeholders at various organizational levels.
Preferred qualifications include experience in cell and gene therapy manufacturing, knowledge of validation principles across multiple disciplines (computerized systems, aseptic process simulation, process validation), and familiarity with pre-clinical, clinical, and commercial cGMP applications. Forge Biologics operates from The Hearth, a state-of-the-art 200,000-square-foot facility dedicated to advancing gene therapy manufacturing and bringing life-changing treatments to patients with genetic diseases.
