Engineer I, Quality Engineering
Arrowhead Pharmaceuticals
August 17, 2026
Remote friendly (Madison, WI)
United States
Operations
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.
Responsibilities
- 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.
Requirements
- 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.
Preferred
- Experience with electronic document management systems in regulated environments.
Compensation/Benefits (if stated)
- Wisconsin pay range: $95,000–$125,000 USD.
- Competitive salaries and an excellent benefit package.
Application Instructions
- Candidates must have current, valid authorization to work in the country where the role is located.
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.
Responsibilities
- 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.
Requirements
- 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.
Preferred
- Experience with electronic document management systems in regulated environments.
Compensation/Benefits (if stated)
- Wisconsin pay range: $95,000–$125,000 USD.
- Competitive salaries and an excellent benefit package.
Application Instructions
- Candidates must have current, valid authorization to work in the country where the role is located.