CSV Engineer

Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.

The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.

Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.

Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.

• Approximately 5-10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
• Strong Computer System Validation experience.
• Experience supporting validation of GMP computerized systems.
• Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
• Understanding of data integrity and GMP expectations for computerized systems.
• Equipment validation / CQV experience in addition to CSV.
• Ability to execute established validation protocols and clearly document results.
• Experience investigating and documenting validation discrepancies or execution issues.
• Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
• ValGensis is a plus
• Develop, review, and execute Computer System Validation (CSV) deliverables for GMP-regulated computerized systems.
• Support the full CSV lifecycle, including validation planning, requirements gathering, risk assessments, testing, traceability, and validation reporting.
• Prepare and maintain URS, Functional/Design Specifications, validation plans, risk assessments, traceability matrices, test scripts, protocols, and summary reports.
• Execute approved validation protocols and accurately document test results and evidence.
• Perform GxP impact assessments and assess computerized systems for compliance with applicable regulatory requirements.
• Ensure systems comply with GMP, GxP, 21 CFR Part 11, EU Annex 11, and Data Integrity requirements.
• Support CSV/CSA assessments and apply risk-based validation approaches.
• Investigate, document, and resolve validation discrepancies, deviations, and exceptions.
• Support change control, CAPA, corrective actions, and periodic review activities.
• Maintain complete, accurate, and inspection-ready validation documentation.
• Collaborate with Quality Assurance, IT, Engineering, Automation, Manufacturing, Regulatory, and system owners.
• Support validation of applications such as MES, LIMS, ERP, laboratory systems, manufacturing systems, and cloud-based GxP applications.
• Participate in software testing, integration testing, UAT, regression testing, and data integrity verification.
• Coordinate with vendors and technical teams during system implementation, upgrades, remediation, and retirement.
• Support audits and regulatory inspections by providing validation documentation and technical evidence.
• Identify compliance gaps and recommend appropriate remediation or risk mitigation strategies.
• Contribute to continuous improvement of CSV processes, templates, procedures, and validation methodologies.
• Use electronic validation platforms such as ValGenesis, Kneat, or similar systems where applicable.