Computer System Validation (CSV) Engineer
The Computer System Validation (CSV) Engineer will be responsible for ensuring that computerized systems within the process automation framework are validated in compliance with regulatory requirements and industry standards.
This role involves developing validation protocols, executing tests, and documenting activities to ensure systems meet operational and regulatory expectations. The CSV Engineer will collaborate closely with cross-functional teams to support quality and efficiency in manufacturing and process automation.
The successful CSV Engineer will be qualified with a Bachelor’s Degree in Engineering, Computer Science, Life Sciences, or a related field. A minimum of 5 years of experience in computer system validation in a regulated environment (e.g., pharmaceuticals, biotechnology, food processing).
Key Responsibilities:
Validation Planning and Execution:
- Develop and execute validation strategies for new and existing computerized systems used in process automation.
- Author and review validation documents, including Validation Plans, User Requirements Specifications (URS), Functional Requirement Specifications (FS), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
- Perform risk assessments to determine the scope and rigor of validation activities.
Regulatory Compliance:
- Ensure compliance with regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other relevant standards.
- Maintain validation documentation to meet audit and inspection readiness.
- Collaborate with Quality Assurance to address compliance gaps and improve validation processes.
Testing and Verification:
- Design and execute test cases to verify system functionality, data integrity, and performance.
- Investigate and resolve validation test deviations or failures.
- Develop traceability matrices to link requirements to validation testing outcomes.
System Lifecycle Management:
- Support the implementation and validation of systems such as Distributed Control Systems (DCS – Emerson DeltaV), Siemens based PLCs, Pi and other automation platforms.
- Ensure proper change control and impact assessments for validated systems.
- Participate in periodic reviews and re-validation activities to ensure continued compliance and performance.
Documentation and Reporting:
- Create detailed and accurate documentation for all validation activities, ensuring traceability and alignment with project requirements.
- Prepare validation summary reports and maintain system validation status.
- Support audit responses and inspections by providing necessary validation documentation and system information.
Arcadis | DPS Group is a leading Project Management and Engineering Company delivering Full-Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time.
Arcadis | DPS Group is an Equal Opportunities Employer.
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