I am currently working with a growing pharmaceutical group based in Indianapolis. They are currently looking to recruit a highly skilled Computer System Validation (CSV) Lead to support the release of a new line. You will ensure compliance with regulatory requirements and industry standards for computer systems within our organization. 

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.

• Identify and implement process improvements in validation activities to enhance efficiency and compliance.

• Provide training and guidance to team members on validation requirements and best practices.

Qualifications & Experience:

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

• Minimum 5 years of experience in Computer System Validation within regulated industries (Pharmaceutical, Biotechnology, Medical Devices, etc.).

• Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards.

• Proficient in writing technical documentation and validation reports.

• Excellent problem-solving skills and attention to detail.

• Strong communication and teamwork skills.