Engineer I, Quality Engineering

Scorpion Therapeutics; Madison (WI); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Job summary

Scorpion Therapeutics seeks a Quality Assurance professional to lead analytical method validation activities supporting pre-clinical through commercialization. The role provides expert guidance on validation strategies, documentation, and data integrity within GMP frameworks.

The successful candidate will mentor QA staff, review vendor data, and support deviations, change controls, and CAPAs to uphold validated systems and commissioning efforts across commercial manufacturing.

Qualifications

• Bachelor’s degree in science required.
• 8+ years in cGMP-regulated manufacturing, specifically method validation roles.
• Strong knowledge of GMP regulations (ICH Q2, ICH Q7, 21 CFR 210/211, EU Annex 11/15, 21 CFR 11).
• Excellent attention to detail and communication.
• Ability to multi-task with minimal supervision.
• Proficiency with Word and Excel.

Responsibilities

• Serve as QA SME for method validation; guide validation strategies and documentation.
• Draft, review, and approve qualification/validation procedures.
• Mentor QA staff in quality engineering (procedures, audits, method validation).
• Review internal and vendor data for validation/qualification; assess equipment suitability; support audits.
• Support deviations, change controls, and CAPAs related to validation.
• Develop periodic reviews of validated systems/processes, including CPV for commercial manufacturing.

Skills

Attention to detail

Organizational skills

Communication skills

Multi-tasking

Education

Bachelor's degree in science

Tools

Microsoft Word

Microsoft Excel

Job description

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.