What are the responsibilities and job description for the CSV Engineer (276) position at Realta Technologies?
Réalta Technologies is a leading automation and digital system firm that specializes in delivering innovative solutions to clients in the life science industries. We are seeking a highly motivated CSV Engineer to join our team supporting a Pharmaceutical client based in Indianapolis, Indiana.
Responsibilities
- Gather and document user requirements, ensuring alignment with regulatory and business needs.
- Develop and manage validation deliverables, including VMP, IQ, OQ, and PQ protocols, adhering to paper-based validation processes.
- Conduct risk assessments to identify and mitigate potential issues, ensuring compliance with GAMP 5 and data integrity principles (ALCOA ).
- Develop and execute test scripts to verify system functionality, ensuring compliance with FDA 21 CFR Part 11 and EU GMP Annex 11.
- Implement and manage a change control process for system modifications, ensuring ongoing compliance.
- Provide training to users on validation processes and system functionality, ensuring proper system use and maintenance.
- Prepare validation documentation for internal and external audits, ensuring readiness for regulatory inspections.
- Support system maintenance, periodic reviews, and revalidation activities throughout the system's lifecycle.
Requirements
- In-depth understanding of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11.
- Proven experience in developing and managing validation protocols (VMP, IQ, OQ, PQ).
- Proficiency in conducting risk assessments, such as FMEA, for system validation.
- Ability to create and execute test scripts to validate system functionality and compliance.
- Skilled in managing paper-based validation documentation with a focus on traceability and accuracy.
- Experience implementing and maintaining robust change control processes.
- Effective in delivering user training and facilitating knowledge transfer.
- Familiarity with preparing documentation and supporting regulatory audits.
