Job Description
We are seeking a highly experienced and detail-oriented FDA Computer System Validation (CSV) Lead to ensure compliance with FDA and other authorized body (TUV, BSI, etc.) regulations and guidelines for computer systems within our organization. As the CSV Lead, you will be responsible for overseeing the validation of computer systems used in the development, manufacturing, and distribution of FDA-regulated products. You will collaborate with cross-functional teams to develop and execute validation strategies, ensure documentation and testing protocols meet regulatory requirements, and drive the successful implementation of validated systems.
What will you do:
- Lead and manage the end-to-end Computer System Validation (CSV) lifecycle, including planning, execution, documentation, and approvals.
- Develop, review, and maintain CSV deliverables such as validation plans, protocols, risk assessments, traceability matrices, and final reports.
- Ensure compliance with FDA regulations, industry standards, and internal quality requirements for regulated computer systems.
- Collaborate with business stakeholders, IT teams, vendors, Quality, and Compliance to define and execute validation requirements and strategies.
- Conduct risk assessments and impact analyses to determine critical system functions and appropriate validation approaches.
- Design and execute validation testing activities, including IQ, OQ, PQ, and UAT, ensuring systems meet business and regulatory requirements.
- Provide oversight, guidance, training, and subject matter expertise on CSV best practices to validation teams and key stakeholders.
- Drive continuous improvement of the CSV program, support audits and inspections, and resolve validation-related deviations and compliance issues.
What you need:
- Bachelor's degree in Computer Science, Engineering, or a related field. Advanced degree is a plus.
- Minimum of 3 year’s experience in FDA-regulated industries, with a strong focus on computer system validation.
- Thorough understanding of FDA regulations and guidelines related to CSV, including 21 CFR Part 11, 21 CFR Part 820, and GAMP (Good Automated Manufacturing Practice) standards.
- Proven experience leading and managing CSV activities for complex computer systems in a regulated environment.
- Excellent knowledge of CSV methodologies, validation protocols, risk management, and change control processes.
- Strong understanding of software development life cycle (SDLC) methodologies, including agile and waterfall approaches.
- Familiarity with various types of computer systems used in FDA-regulated processes, such as laboratory information management systems (LIMS), electronic data capture (EDC) systems, and manufacturing execution systems (MES).
- Strong project management skills with the ability to effectively plan, prioritize, and execute multiple validation projects concurrently.
- Excellent written and verbal communication skills, including the ability to communicate complex concepts and requirements to both technical and non-technical stakeholders.
- Strong analytical and problem-solving abilities, with a keen attention to detail.
- Knowledge of validation tools, testing methodologies, and automated validation solutions is a plus.
- Experience with electronic document management systems (EDMS) and validation software is preferred.
