Computer Systems Validation Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Drive and enhance the Computer System Validation capability throughout IT by defining the validation strategy, operational model, standards, and a risk-based methodology.

• Establish and nurture the CSV team, which includes recruitment, onboarding, mentoring, and the professional development of additional CSV Engineers.

• Create, review, execute, and maintain validation lifecycle deliverables such as validation plans, requirements, risk assessments, specifications, test protocols and scripts, traceability matrices, and validation summary reports.

• Identify validation scope, testing depth, and evidence requirements through a documented risk-based approach.

• Carry out or coordinate qualification and verification activities, including installation, operational, performance, user acceptance, and other risk-based assurance testing.

• Evaluate changes to validated systems, assess validation impact, support regression testing, and ensure the implementation of approved change control.

• Conduct validation maintenance, periodic reviews, access and audit-trail reviews, revalidation assessments, and provide support for retirement or decommissioning processes.

• Assist in the investigation and resolution of validation deviations, test exceptions, incidents, and compliance gaps, contributing to Corrective and Preventive Actions (CAPAs) when necessary.

• Compile validation records and evidence packages for audits, regulatory inspections, and due diligence activities.

• Collaborate with system owners, business process owners, Quality, IT, technical teams, and vendors.

• Continuously enhance validation procedures, templates, standards, metrics, and training materials.

• Utilize approved automation and AI-assisted tools to increase validation efficiency while independently assessing outputs.

⛳️ Requirements

• Bachelor's degree in engineering, computer science, information systems, life sciences, or a related field; equivalent relevant experience may be accepted.

• Extensive experience in biotechnology, pharmaceuticals, medical devices, healthcare, or another regulated sector.

• Strong background in Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles.

• Proven capability to lead validation activities across multiple computerized systems and projects.

• Experience in supporting regulatory inspections, audits, validation assessments, and quality-system documentation.

• In-depth knowledge of GxP requirements, GAMP 5, risk-based CSV/CSA principles, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, change control, deviations, CAPA, and document control.

• Familiarity with functional risk assessments, requirements traceability, supplier assessments, change control, deviations, CAPA, and periodic review.

• Experience in authoring, reviewing, or executing IQ, OQ, PQ, UAT, or similar risk-based verification documentation.

• Knowledge of scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools is a plus.

• Regular use of a computer, devices, or other office equipment, effective communication skills, and occasional mobility.

🏝️ Benefits

• Equal opportunity employer.

• Reasonable accommodations for individuals with disabilities.

• Occasional travel as necessary.