Validation Engineer II

Role: Validation Engineer II responsible for implementing and maintaining validation processes for new systems within a biopharma manufacturing environment. Objectives include ensuring compliance with regulatory standards, executing validation activities, and establishing a periodic review program for validated systems. Responsibilities: draft validation documents (validation plans, URS, IQ/OQ/PQ protocols, risk assessments), execute test scripts adhering to GxP, manage project timelines, monitor quality systems (CAPA, deviations, change controls), support audits, and develop SOPs and training materials. Qualifications: Bachelor’s degree in Science, Engineering, or related field; 5+ years in biotech or pharmaceutical industry, with experience in GxP regulated environments. Preferred skills include knowledge of 21 CFR Parts 11, 210, 211, GAMP 5, and USP, along with experience in deviations, CAPAs, and Change Controls. HighValue: focus on validation within manufacturing or laboratory settings, ensuring compliance with FDA and other regulatory standards, supporting systems lifecycle management. Work setup: on-site in Stafford, TX, with standard weekday schedule; travel not specified.