Validation Engineer II

Role: Validation Engineer focused on commissioning and qualification of equipment, facilities, and utilities within a biopharma manufacturing environment. Objectives include ensuring safety, performance, reliability, and compliance of new or modified assets to support manufacturing and quality operations. Responsibilities encompass developing and executing validation protocols (IQ/OQ/PQ), managing small to medium projects across facilities, utilities, and automation systems, and maintaining validation records using systems like Kneat and CMMS. The role also supports quality investigations, CAPA, and site cleaning validation. Requirements: Bachelor’s degree in engineering, science, or related field; 3+ years’ experience in validation engineering, ideally within pharmaceutical, medical device, or related industries. Experience in developing validation deliverables and working within cGMP frameworks is highly desired. Preferred skills include knowledge of clean validation, temperature mapping, and validation of controlled temperature units. The position requires strong interpersonal and communication skills, with an understanding of regulatory standards. High-value specifics include validation expertise in pharma/medical device environments, experience with equipment and system testing protocols, and familiarity with GxP validation practices. Work setup and travel details are not specified.