Senior Validation Engineer

Role: Senior Validation Engineer supporting manufacturing process, equipment, utility, and sterilization validations in a biopharma manufacturing environment. Responsibilities include developing validation plans and protocols, executing qualification and requalification activities, troubleshooting, supporting audits, and ensuring compliance with regulations. The role involves cross-functional collaboration for scheduling and completing validation tasks, conducting process capability analyses, and supporting change controls and risk assessments. Qualifications: Bachelor's degree with 2+ years, or higher degrees with less experience; experience in pharma validation, sterile products, or medical devices preferred. Skills: strong technical validation knowledge, analytical problem-solving, organizational skills, and familiarity with regulatory audits. High-Value Details: Involves aseptic gowning, working in a penicillin manufacturing facility, supporting sterile media fill, steam sterilization, and laboratory equipment validation. Requires working in a GxP regulated environment with occasional non-standard shifts and minimal travel. Work setup is on-premise, with relocation support available.