Senior Validation Engineer I

Role: Senior Validation Engineer I supporting biopharma manufacturing validation programs at a site in Lexington, MA. Primary objectives include executing validation strategies and maintaining compliance for facilities, utilities, equipment, sterilization, and analytical instruments. Responsibilities encompass developing and executing qualification protocols, managing validation projects, overseeing requalification activities, and ensuring adherence to GMP, FDA, and ISO standards. The role involves cross-functional collaboration with project teams, managing vendor proposals, and authoring validation documentation such as protocols and final reports. Requirements include a Bachelor's degree in Mechanical Engineering or related field, with at least 30 months of experience in validation for facilities, utilities, and equipment in regulated environments, including IQ/OQ/PQ, CAPA investigations, and validation maintenance. Preferred skills include experience with automation platforms, analytical instruments, and validation in sterile manufacturing settings. The position is full-time, with up to 20% remote work, and involves working within GMP and FDA-compliant frameworks, with an annual salary range of $104,541 to $141,240.