Lead Quality Engineer — Validation & Compliance

Scorpion Therapeutics; Madison (WI); On-site; USD 125,000 - 140,000; Full time

Job summary

Scorpion Therapeutics is seeking a Quality Assurance expert to lead qualification, cleaning and process validation, and CPV activities in a GMP manufacturing environment in Wisconsin. You will guide, review, and approve system requirements, design, risk assessments, and validation documentation, and mentor other QA members.

Responsibilities include drafting validation procedures, supporting deviations, change controls, CAPAs, and liaising with cross-functional teams to ensure timely validation

Qualifications

• Bachelor’s degree in a science field required.
• 15+ years of experience in cGMP-regulated manufacturing, specifically in validation-related roles in manufacturing and/or quality.
• Excellent attention to detail and organizational skills; ability to multitask with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.

Responsibilities

• Lead QA expert on qualification, cleaning validation, process validation, and CPV; guide, review, and approve validation documentation.
• Draft, review, and approve qualification/validation procedures and support GMP quality systems.
• Mentor Quality Assurance members on QA functions (audits, cleaning validation, equipment qualification, CPV).
• Collaborate with cross-functional teams to review validation data and documentation.
• Support deviations, change controls, and CAPAs related to validation.

Skills

Quality Assurance

Validation

CPV

Documentation

Education

Bachelor’s degree in a science field

Tools

Microsoft Word

Excel

Job description

Scorpion Therapeutics is seeking a Quality Assurance expert to lead qualification, cleaning and process validation, and CPV activities in a GMP manufacturing environment in Wisconsin. You will guide, review, and approve system requirements, design, risk assessments, and validation documentation, and mentor other QA members.

Responsibilities include drafting validation procedures, supporting deviations, change controls, CAPAs, and liaising with cross-functional teams to ensure timely validation