Computer Systems Validation Engineer
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Lead computer system validation strategy and team development for Praxis, a clinical-stage biopharmaceutical company. Ensuring compliant, risk-based GxP validation across CNS therapy technology systems.
Responsibilities:
- Lead and scale the Computer System Validation capability across IT, defining the validation strategy, operating model, standards, and risk-based approach
- Build and develop the CSV team, including hiring, onboarding, mentoring, and developing additional CSV Engineers
- Author, review, execute, and maintain validation lifecycle deliverables, including validation plans, requirements, risk assessments, specifications, test protocols and scripts, traceability matrices, and validation summary reports
- Determine validation scope, test depth, and evidence requirements using a documented risk-based approach
- Execute or coordinate qualification and verification activities, including installation, operational, performance, user acceptance, and other risk-based assurance testing
- Assess changes to validated systems, determine validation impact, support regression testing, and ensure approved change control implementation
- Perform validation maintenance, periodic reviews, access and audit-trail reviews, revalidation assessments, and retirement or decommissioning support
- Support investigation and resolution of validation deviations, test exceptions, incidents, and compliance gaps, contributing to CAPAs when appropriate
- Prepare 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 improve validation procedures, templates, standards, metrics, and training materials
- Use approved automation and AI-assisted tools to improve validation efficiency while independently reviewing outputs
Requirements:
- Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered
- Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment
- Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles
- Demonstrated ability to lead validation activities across multiple computerized systems and projects
- Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation
- Strong 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
- Experience with functional risk assessments, requirements traceability, supplier assessments, change control, deviations, CAPA, and periodic review
- Experience authoring, reviewing, or executing IQ, OQ, PQ, UAT, or equivalent risk-based verification documentation
- Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools is advantageous
- Regular use of a computer, devices, or other office equipment, clear communication, and occasional movement
Benefits:
- Equal opportunity employer
- Reasonable accommodations for individuals with disabilities
- Occasional travel as needed
Similar Jobs
Senior Service Desk Engineer
Senior Service Desk Engineer delivering managed IT and cybersecurity solutions for NetCov clients. Providing advanced troubleshooting, infrastructure optimization, technical leadership, and service desk mentorship.
Integration, Middleware Engineer
Integration/Middleware Engineer designing secure enterprise integrations, APIs, middleware, and cloud data pipelines. Supporting KGS solutions for Federal Government agencies across AWS and Azure Government.
MES Engineer
MES Engineer developing MES integrations and digital manufacturing solutions for Molex, a global connector and interconnection-components provider. Improving production traceability, reliability, and operational efficiency.
Citrix Engineer
Citrix Engineer administering Citrix VDI infrastructure for WCG’s clinical-trial solutions. Managing desktop images, L3 support, platform performance, and business-continuity testing.
Virtualization Engineer
Virtualization Engineer operating enterprise VMware platforms for Bright Vision Technologies’ cloud and software solutions. Automating virtualization, networking, storage, and hybrid-cloud operations.
Data Center Virtualization Engineer
Data Center Virtualization Engineer operating enterprise VMware, networking, and storage platforms. Supporting cloud, AI, data, and enterprise solutions for U.S. clients.
Prin Manufacturing Engineer
Principal Manufacturing Engineer optimizing fixtures, validation, and processes for Medtronic’s medical-device contract manufacturing network. Driving compliant production-line reliability and continuous improvement.
MDM Engineer – 1-month contract
MDM Engineer migrating MySense’s Windows, macOS, iOS, and Android estate. Delivering secure in-house endpoint management for UK health technology company MySense.
Controls Engineer Technician II – Field Service Representative
Field service technician installing, testing, and troubleshooting Active Protection Systems for General Dynamics military vehicles. Supporting customers, suppliers, and contractors through extensive field travel.
Commissioning Engineer
Commissioning Engineer starting up Anaergia’s waste-to-energy and renewable energy facilities across North America. Testing controls, troubleshooting systems, and coordinating safe project handovers.
Plumbing Remedial Engineer
Plumbing Remedial Engineer maintaining commercial and domestic water systems for SMS Environmental across Reading. Performing remedial repairs, testing, disinfection, and compliance reporting.
Plumbing Remedial Engineer
Plumbing engineer performing remedial repairs, water testing, and compliance reporting. SMS Environmental protects UK water systems and environmental safety.
Senior Business Value Engineer
Business Value Engineer quantifying ROI and business value for Grafana Labs’ observability platform. Enabling sales teams through customer insights, value storytelling, and strategic partnerships.
Senior Process Control Engineer – Utilities
Senior process control engineer optimizing utilities and control systems for Georgia-Pacific’s continuous manufacturing mills. Supporting troubleshooting, capital projects, and process performance across U.S. operations.
Forward Deployed Engineer
Forward Deployed Engineer building and deploying agentic AI systems for Redapt clients. Writing production Python and advising on model optimization, security, and ROI.
Civil Project Engineer II/III – Renewable Energy Structural Design
Civil Project Engineer designing steel piles, connections, and concrete slabs for renewable-energy projects at Timmons Group. Supporting scopes, budgets, project management, and proposals.
SCADA Engineer II, EPC
SCADA Engineer II designing and commissioning control systems for SOLV Energy’s utility-scale solar and battery-storage projects. Supporting EPC delivery, NERC compliance, and field integrations.
Test Safety Engineer
Test Safety Engineer ensuring safe autonomous truck testing at Torc Robotics. Developing safety processes, risk assessments, analyses, and compliance plans for automated heavy trucks.
Senior Frontend Engineer, Retail Media / AdTech Solutions
Senior Frontend Engineer building React and TypeScript experiences for Redcare Pharmacy’s Retail Media platform. Delivering advertiser self-service, campaign management, reporting, and AdTech integrations.
Senior Frontend Engineer, Retail Media / AdTech Solutions
Senior Frontend Engineer building React and TypeScript experiences for Redcare Pharmacy’s Retail Media and AdTech platform. Delivering campaign, reporting, and advertiser self-service products.