Computerised Systems Validation Engineer

The Role:

Our client is a leading pharmaceutical company who is dedicated to delivering high quality products and services. They maintain a high standard across all operations by focusing on compliance, efficiency and innovation. They are seeking an experienced Computerised Systems Validation (CSV) Engineer to oversee and execute computer systems validation across the enterprise. The CSV Engineer will ensure that business processes are qualified and maintained in a validated state, in line with company directives and procedures.

Responsibilities:
• Lead the conception, planning and execution of CSV in regulated environments.
• Provide guidance and support to application owners in establishing and maintaining GxP-compliant systems, ensuring adherence to relevant regulations and industry standards.
• Develop strategies and oversee the implementation of qualification/validation requirements for new and existing computer systems.
• Create and implement IT procedures that meet Data Integrity requirements for Raw-Data-Handling systems and solutions as stipulated by applicable regulations.
• Manage and conduct computer system validation activities, ensuring alignment with regulatory requirements, GAMP 5, and the client's guidelines.
• Enhance and implement CSV documentation including Validation Plans (VPs), Test Scripts, Assessments, Reports, Standard Operating Procedures (SOPs), and Policies.
• Assist in the implementation and integration of the global CSV program and support remediation efforts as needed.
• Support data integrity initiatives and remediation efforts within the CSV program.
• Participate in audits and contribute to continuous improvement initiatives related to the CSV program.
• Collaborate to achieve both site-specific and corporate CSV objectives for the client.

Qualifications/Requirements:
• Bachelor's degree in engineering, life sciences, or a related field.
• Minimum of 5 years relevant CSV experience, preferably in the biotech/pharma industries.
• Experience directly working with IT and manufacturing automation systems that support GMP manufacturing.
• Hands-on experience in implementing Computerized Systems Validation (CSV) activities to support GxP systems.
• Direct experience in validating enterprise systems such as ERP, LIMS, and MES.
• Comprehensive understanding of FDA and cGMP regulations and documentation procedures.
• Proficient in GAMP 5 standards.
• Thorough understanding of 21 CFR Part 11 and Annex 11 requirements.
• Expertise in computer system validation methodologies.
• Proven capability to effectively collaborate across functions and communicate with all levels of management.
• Proactive, motivated, analytical and strategic.
• Proficient in validation documentation and technical writing.
• Capable of working independently and collaboratively.
• Effective communication and interpersonal skills.

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For more information and a confidential chat please contact Gerard Cunniffe on (phone number removed)