Validation Engineer

Scorpion Therapeutics; Wisconsin; On-site; USD 65,000 - 95,000; Full time

Job summary

Scorpion Therapeutics in Wisconsin seeks a Validation professional to support qualification, validation, and compliance in a regulated manufacturing environment. You will evaluate protocols, troubleshoot validation issues, and write technical reports.

The role requires a degree with experience or equivalent, strong FDA/GxP knowledge, data analysis skills (Excel), and excellent communication. On‑premise work with potential off-hours and adherence to cGMP.

Qualifications

• Bachelor's degree or equivalent experience in a regulated field.
• Experience with FDA regulations, GxP, and validation principles.
• Proficiency in data analysis and Excel for validation work.

Responsibilities

• Evaluate and review protocols, troubleshoot validation issues, and write technical reports.
• Contribute to validation projects and ensure cGMP compliance.
• Collaborate with cross-functional teams in a regulated manufacturing environment.

Skills

Data analysis

Excel proficiency

Education

Bachelor's degree in a relevant field

Associate's degree with 4+ years

High school diploma with 6+ years

Job description

Role: Validation professional supporting qualification, validation, and compliance activities in a regulated manufacturing environment.

Responsibilities: evaluate and review protocols, troubleshoot validation issues, write technical reports, contribute to validation projects, and ensure adherence to cGMP and industry standards.

Requirements: bachelor's degree with relevant experience, or associate's degree with 4+ years, or high school diploma with 6+ years' experience; strong understanding of FDA regulations, GxP, and validation principles; proficiency in data analysis tools like Excel; excellent communication and organizational skills.

Preferred: technical writing experience, equipment qualification knowledge, collaborative skills, adaptability, and familiarity with AI tools for problem solving.

High-value specifics: manufacturing environment with focus on equipment and process validation, cGMP compliance, and cross-functional collaboration.

Work setup: on-premise with potential off-hours work; physical demands include manufacturing area presence and safety compliance.