Job Description Your RoleWe are seeking Computer System Validation (CSV) Engineers of varying experience levels to support validation and compliance activities for computerized systems used within regulated life sciences environments. The CSV Engineer will be responsible for ensuring computerized systems are implemented, maintained, and operated in compliance with regulatory expectations, data integrity requirements, and client quality standards.
This position supports a wide range of platforms including laboratory systems, manufacturing systems, automation platforms, quality systems, and enterprise applications.
- Develop and execute Computer System Validation documentation in accordance with regulatory requirements and company procedures.
- Author and review validation plans, user requirements specifications, functional specifications, risk assessments, traceability matrices, test scripts, summary reports, and SOPs.
- Support implementation and validation of computerized systems throughout the system lifecycle.
- Execute and document system testing activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT).
- Conduct risk assessments utilizing risk-based validation and CSA methodologies.
- Evaluate computerized systems for compliance with data integrity and electronic records requirements.
- Support change control, deviation investigations, CAPA activities, and periodic system reviews.
- Collaborate with Quality Assurance, IT, Automation, Engineering, Manufacturing, and Laboratory Operations teams.
- Participate in software implementation projects, upgrades, migrations, and system enhancements.
- Ensure validated-state maintenance through lifecycle management activities.
- Support regulatory inspections, audits, and client reviews.
- Maintain project documentation and ensure compliance with client and industry standards.
- Travel to client sites as required to support system implementation and validation efforts.
Requirements- Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
- Experience supporting computerized system validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
- Understanding of GxP regulations, data integrity requirements, and computerized system compliance principles.
- Experience authoring CSV lifecycle documentation and executing validation testing.
- Familiarity with risk-based validation methodologies and Computer Software Assurance (CSA) concepts.
- Knowledge of electronic records and electronic signature requirements.
- Strong technical writing and documentation skills.
- Excellent analytical, troubleshooting, and problem-solving capabilities.
- Strong communication and stakeholder management skills.
- Ability to manage multiple projects and priorities simultaneously.
- Ability and willingness to travel as required by client projects.
- Must be authorized to work in the U.S.
- No C2C at this time.
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