CSV Lead

We are working with a large pharmaceutical manufacturing group based in Indianapolis. They are currently looking to recruit a highly skilled CSV Lead to support the release of a new line. Please see details below:

Key Responsibilities:

• Develop and implement Computer System Validation strategies, protocols, and procedures.
• Conduct risk assessments to determine validation requirements for new and existing computer systems.
• Author and execute validation documentation, including Validation Plans, IQ/OQ/PQ protocols, and summary reports.
• Ensure compliance with relevant regulatory requirements (FDA, EMA, GAMP 5, ISO, and other industry standards).
• Collaborate with IT, Quality Assurance, and business teams to ensure proper system validation.
• Participate in system development life cycle (SDLC) activities and provide validation support during implementation.
• Manage and execute periodic system reviews and re-validation to ensure ongoing compliance.
• Support audits and regulatory inspections by providing validation documentation and addressing compliance-related inquiries.

Qualifications & Experience:

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• Minimum 10 years of experience in Computer System Validation within regulated industries (Pharmaceutical, Biotechnology, Medical Devices, etc.).
• Strong knowledge of Manufacturing Experience within the FDA Industry
• Software Qualification knowledge
• Knowledge of leverage testing
• Experience handling deviations
• Experience qualifying SCADAs, PLC, PIE and DCS systems

Location - Indianapolis, Indiana

Duration: 12 months with a view to an extension at the end

Rate: $ flexible depending on experience

Please apply only if you have the desired skillset and experience so we can send your resume to the client and arrange interviews asap!