Lead Computer Systems Validation Engineer I (Clinical & R&D)

Scorpion Therapeutics; United States; Hybrid; USD 110,000 - 126,000; Full time

Benefits offered by this job

Hybrid work (60% office/40% home)

Onsite in Waltham, MA 3 days/week

Annual performance bonus

Job summary

Scorpion Therapeutics seeks an experienced CSV leader to support validation across Quality, Regulatory, and R&D systems in a GxP environment. You will represent CSV in cross-functional teams and drive risk-based validation using GAMP 5 and Quality Risk Management.

You will develop and maintain validation documentation, conduct risk assessments, and communicate outcomes to auditors. Hybrid work with on-site presence in the US is offered.

Qualifications

• Bachelor’s or Master’s in a relevant field with extensive GxP validation experience (9+ years or 7+ years with Master’s).
• Proven CSV experience in a GxP environment; quality systems, compliance, and data integrity expertise.
• Knowledge of GxP regulations (21 CFR Part 11/312/314, ICH Q7/Q8/Q9/Q10).
• Strong leadership, collaboration, written/verbal communication, and time management; ability to work cross-functionally.

Responsibilities

• Support computer system validation (CSV) across Quality, Regulatory, and R&D systems in a compliant manner.
• Represent CSV in project teams and track progress with stakeholders.
• Apply risk-based validation using GAMP 5 and Quality Risk Management.
• Develop, review, approve, and execute validation documentation across the system lifecycle.
• Conduct/approve risk assessments per Quality Risk Management policy.
• Communicate validation outcomes to reviewers/auditors.
• Maintain GxP compliance through monitoring, validation, and system lifecycle activities.
• Create/maintain CSV templates in ValGenesis and related job aids.
• Support regulatory inspections, internal audits, and third-party audits.

Skills

Leadership

Cross-functional collaboration

Communication

Time management

Education

Bachelor’s in computer science, Life Sciences, Engineering, or related field

Master’s degree in related field

Tools

LMS

Veeva DMS

TrackWise

ValGenesis

Job description

Responsibilities:

• Support computer system validation (CSV) activities across Quality, Regulatory, and R&D systems, ensuring compliance with regulations, internal policies, and SOPs.
• Represent CSV in project teams; collaborate with stakeholders; measure and report execution progress.
• Apply risk-based validation using tools such as GAMP 5 and Quality Risk Management.
• Develop, review, approve, and execute validation documentation across the system lifecycle.
• Conduct/approve risk assessments per the company Quality Risk Management policy.
• Communicate validation outcomes clearly to reviewers/auditors.
• Apply technical/scientific knowledge to validation approaches and documentation.
• Exposure to validation of AI and AI validation methodology.
• Maintain GxP compliance through monitoring/review/assessment/qualification (Change Control, Deviations, CAPAs, Periodic Reviews, Access Reviews, SOP updates).
• Support compliance with corporate global computerized validation policies and Digital Quality expectations.
• Create/maintain CSV templates in ValGenesis and relevant job aids.
• Support regulatory inspections, internal audits, and third-party/vendor audit activities (including corrective actions to closure).
• Provide training before CSV activities begin; lead/assist validation methodology training content.
• Participate in cross-functional forums and track action items.
• Participate in professional/industry groups.

Qualifications:

• Bachelor’s in computer science, Life Sciences, Engineering, or related field; 9+ years Digital Quality experience in GxP pharma/biotech (or Master’s with 7+ years).
• Preferred: experience supporting CSV in a GxP environment. Required: quality systems, compliance, and data integrity experience, including enterprise quality systems (e.g., LMS, Veeva DMS, TrackWise) and paperless validation platforms (e.g., ValGenesis).
• Knowledge of GxP regulations (e.g., 21 CFR Part 11/312/314, EudraLex Vol 4 & Annex 11, ICH Q7/Q8/Q9/Q10).
• Strong leadership, collaboration, written/verbal communication, and time management; proven results; ability to work cross-functionally; flexibility.

Benefits/Compensation & Work Model:

• Base salary: $110,000–$126,000; annual performance bonus; hybrid work (60% office/40% home), onsite at Waltham, MA at least 3 days/week; not fully remote.