Senior CSV Engineer — Lead Validation & Compliance (Remote)

Scorpion Therapeutics; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior validation lead to scale CSV across IT, defining strategy and building the team. You will author and maintain CSV deliverables, perform risk-based scoping, and coordinate IQ/OQ/PQ/UAT efforts to ensure data integrity and regulatory readiness.

The role requires strong GxP knowledge, experience with audits/inspections, and a track record of improving validation processes. Remote work options may be considered for qualified candidates.

Qualifications

• BS in engineering/CS/IS/life sciences (or equivalent experience).
• Significant regulated-industry experience (biotech/pharma/medical devices/healthcare).
• Strong CSV, Computer Software Assurance, quality systems, and data integrity knowledge.
• Ability to lead validation across multiple systems/projects.
• Experience with regulatory inspections/audits/validation assessments and quality documentation.
• Strong GxP knowledge (GAMP 5, risk-based CSV/CSA; 21 CFR Part 11, EU Annex 11 as applicable; ALCOA+; change control, deviations, CAPA, document control).
• Experience with functional risk assessments, traceability, supplier assessments, periodic review.
• Experience with IQ/OQ/PQ/UAT (or equivalent).
• Travel as needed; remote possible.

Responsibilities

• Lead and scale Computer System Validation (CSV) capability across IT: define validation strategy, operating model, standards, and risk-based approach; build and develop the CSV team.
• Author, review, execute, and maintain CSV lifecycle deliverables (validation plans, requirements, risk assessments, design/config specs, test protocols/scripts, traceability matrices, validation summary reports).
• Build/develop CSV team (hiring, onboarding, mentoring, developing CSV Engineers).
• Use documented, risk-based approach to determine validation scope, test depth, and evidence requirements (intended use, patient safety/product quality, data integrity, regulatory impact).
• Execute/coordinate qualification & verification (installation, operational, performance, user acceptance, other risk-based assurance testing).
• Assess validated system changes; determine validation impact; support regression testing; ensure changes follow approved change control.
• Perform validation maintenance (periodic reviews, access/audit-trail reviews as applicable, revalidation assessments, retirement/decommissioning support).
• Support deviation/test exception/incident resolution; contribute to CAPA.
• Prepare validation records/evidence packages for audits, inspections, due diligence.
• Collaborate with owners/Quality/IT/technical teams/vendors to deliver practical, scalable validation strategies.
• Continuously improve procedures, templates, standards, metrics, and training; use approved automation/AI tools with independent review.

Skills

CSV

Quality systems

Data integrity

Regulatory inspections

GxP knowledge

Validation leadership

Scripting

SQL

eDMS

CAPA

Education

BS in Engineering/CS/IS/Life Sciences

Tools

SQL

eDMS

Job description

Scorpion Therapeutics is seeking a senior validation lead to scale CSV across IT, defining strategy and building the team. You will author and maintain CSV deliverables, perform risk-based scoping, and coordinate IQ/OQ/PQ/UAT efforts to ensure data integrity and regulatory readiness.

The role requires strong GxP knowledge, experience with audits/inspections, and a track record of improving validation processes. Remote work options may be considered for qualified candidates.