Engineer , Quality Engineering

The Position

This Quality Assurance role supports commercialization quality programs, providing leadership and guidance on analytical method verification/validation for pre-clinical/clinical and commercialization activities, including GMP quality systems.

• Serve as Quality Assurance subject matter expert for method validation; provide guidance/review/approval of validation strategies and validation documentation; review data for good documentation practices and data integrity.
• Draft, review, and approve qualification/validation procedures.
• Mentor QA staff in quality engineering functions (procedures, audits, method validation, validation assessments).
• Review/approve internal and vendor data/documentation for validation, qualification, and commissioning; assess suitability of equipment for validated method execution; support internal/external audits.
• Support issuance, review, tracking, and approval of deviations, change controls, and CAPAs related to validation.
• Develop/implement periodic reviews of validated systems/processes, including CPV procedures for commercial manufacturing.

• Bachelor’s degree (or higher) in a science field.
• Bachelor’s degree with 8+ years in cGMP-regulated manufacturing, specifically method validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (ICH Q2, ICH Q7, 21 CFR 210/211, EU Annex 11/15, 21 CFR 11).
• Excellent attention to detail; strong organizational and communication skills.
• Ability to multi-task/prioritize with minimal supervision.
• Proficient with Microsoft Word and Excel.

• Experience with electronic document management systems in regulated environments.

• Wisconsin pay range: $95,000–$125,000 USD.
• Competitive salaries and an excellent benefit package.

• Candidates must have current, valid authorization to work in the country where the role is located.