Biopharma Validation Specialist — GxP & Systems QA

Scorpion Therapeutics; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics seeks a Quality Assurance Validation Associate to lead oversight of validation deliverables, ensuring compliance with regulatory standards and internal SOPs. You will review and approve validation documents across facilities, utilities, equipment, process qualification, cleaning, QC methods, and computer system validation.

The role requires a Bachelor's in a related field and at least 5 years in pharmaceutical/biotech validation, with hands-on experience using Veeva and

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, or related field.
• Minimum 5 years of experience in pharmaceutical/biotech validation.
• Proficiency with validation protocols and electronic document systems (Veeva, Kneat).
• Deep knowledge of GMP/EU regulations and GxP guidelines.

Responsibilities

• Evaluating validation master plans, qualification protocols, and change controls.
• Supporting validation for manufacturing systems and addressing risk assessments.
• Participating in audits.

Skills

GxP awareness

Auditing

Risk assessment

Documentation

Education

Bachelor's degree in Biotechnology, Microbiology, Pharmacy, or related field

Tools

Veeva

Kneat

Electronic document systems

Job description

Scorpion Therapeutics seeks a Quality Assurance Validation Associate to lead oversight of validation deliverables, ensuring compliance with regulatory standards and internal SOPs. You will review and approve validation documents across facilities, utilities, equipment, process qualification, cleaning, QC methods, and computer system validation.

The role requires a Bachelor's in a related field and at least 5 years in pharmaceutical/biotech validation, with hands-on experience using Veeva and