Engineer I, Quality Engineering (Analytical Method Validation)

Role: Senior Quality Assurance specialist supporting commercialization programs with a focus on analytical method verification/validation in GMP manufacturing. Responsibilities: lead and review validation strategies, review and approve validation documentation, serve as SME on method validation, mentor QA team members, assess validation changes/deviations, support audits, and contribute to maintaining quality systems supporting GMP; work across departments to ensure compliance and data integrity. Requirements: Bachelor’s in science with 8+ years experience in cGMP-regulated manufacturing, expertise in method validation, knowledge of GMP regulations (ICH Q2, Q7, 21CFR Part 210/211), strong organizational and communication skills, proficient in MS Office. Preferred: experience with electronic document management systems. High-Value: focus on analytical method validation for biologics or small molecules, GMP compliance, validation documentation, and cross-functional collaboration. WorkSetup: not specified; based in Wisconsin with a focus on supporting commercial manufacturing.