Computer Systems Validation Engineer

Scorpion Therapeutics; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead Computer System Validation Engineer to shape and scale CSV strategies within a GxP environment, enabling rapid development while maintaining compliance.

You will define validation frameworks, author lifecycle deliverables, and lead a growing validation team. The role emphasizes risk-based validation, collaboration with IT, Quality, vendors, and business owners, plus integrating automation tools to boost efficiency.

Qualifications

• Bachelor's degree in engineering, computer science, or related field; significant experience in biotech, pharma, or regulated settings with strong CSV, data integrity, and GxP knowledge.
• Experience supporting audits and validation activities; familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation principles.

Responsibilities

• Define validation frameworks, authoring and executing lifecycle deliverables.
• Lead validation team growth and oversee changes.
• Maintain validation systems and support audits and regulatory inspections.
• Collaborate with IT, Quality, vendors, and business owners; integrate automation tools to improve efficiency.

Skills

GxP knowledge

Regulatory compliance

Audit readiness

Leadership

Education

Bachelor's degree in engineering, computer science, or related field

Tools

Scripting

SQL

Test automation

EDMS

Job description

Role

Lead Computer System Validation Engineer responsible for shaping and scaling CSV strategies within a GxP environment, ensuring compliance while enabling rapid development.

Responsibilities

Defining validation frameworks, authoring and executing lifecycle deliverables, leading validation team growth, assessing changes, maintaining validation systems, and supporting audits and regulatory inspections. The role emphasizes risk-based validation, collaboration with IT, Quality, vendors, and business owners, and the integration of automation tools to improve efficiency.

Qualifications

Bachelor's degree in engineering, computer science, or related field; significant experience in biotech, pharma, or regulated settings with strong CSV, data integrity, and GxP knowledge; experience supporting audits and validation activities; familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation principles.

Preferred Skills

scripting, SQL, test automation, and electronic document management systems.

Location and Work Arrangement

The position may be remote with travel as needed and involves working within a fast-growing biotech company focused on CNS therapies, requiring a self-driven, ownership-oriented mindset.