Job Description

• Lead and execute Computer System Validation (CSV) projects, ensuring all systems are compliant with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

• Develop and author CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Risk Assessments, Test Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.

• Perform gap assessments and remediation activities for legacy systems to ensure they meet current regulatory standards.

• Collaborate with cross-functional teams, including IT, Quality Assurance, Manufacturing, and R&D, to ensure systems are validated and maintained in a state of control.

• Provide CSV expertise during the selection and implementation of new systems, ensuring that validation activities are integrated into the project lifecycle.

• Conduct training sessions and workshops for stakeholders on CSV processes and regulatory compliance.

• Support audits and inspections by regulatory bodies by providing CSV documentation and expertise.

• Maintain awareness of industry trends and regulatory changes that may impact CSV practices.

• Bachelor's degree in engineering, Computer Science, Life Sciences, or a related field.

• Minimum of 5 years of experience in Computer System Validation in the biotech, pharmaceutical, or medical device industry.

• In-depth knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other relevant regulations and guidelines.

• Proven experience in authoring and executing validation documents (IQ/OQ/PQ) for various computerized systems, including laboratory systems, manufacturing systems, and enterprise applications.

• Strong understanding of risk-based validation approaches.

• Excellent documentation skills with a high level of attention to detail.

• Strong problem-solving abilities and the capacity to work independently and collaboratively in a fast-paced environment.

• Excellent communication and interpersonal skills.

• Experience with Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and Manufacturing Execution Systems (MES).

• Previous experience working in a gene therapy or biotechnology environment.

• Certification in Computer System Validation or related areas is a plus.

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