Computer System Validation (CSV) Engineer – Biotech
Our client based in Melbourne is seeking an experienced Computer System Validation (CSV) Engineer to support GMP-regulated automation and data systems within pharmaceutical and biotechnology manufacturing environments.
Key Duties
- Own and deliver Computer System Validation (CSV) activities for GMP automation and data systems.
- Develop and execute validation documentation in accordance with GAMP 5, Annex 11 and 21 CFR Part 11 requirements.
- Author and manage Installation Qualification (IQ), Operational Qualification (OQ), risk assessments, traceability matrices and validation reports.
- Prepare, review and execute CSV documentation and testing activities for new and existing systems.
- Review and approve validation documentation to ensure compliance with quality and data integrity requirements.
- Conduct records review assessments and quality assurance reviews of technical documentation, including User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS).
- Coordinate with cross-functional teams to ensure compliance with GMP and regulatory requirements.
- Support commissioning and qualification activities, including Site Acceptance Tests (SAT) and Factory Acceptance Tests (FAT).
- Implement automation changes through formal change control procedures.
- Provide technical support for automation systems and troubleshoot hardware, communications and configuration issues.
- Maintain validation records and ensure adherence to ALCOA+ data integrity principles.
Required Skills and Experience
- Bachelor's degree in Engineering, Biotechnology, Automation, or a related discipline.
- Demonstrated experience in Computer System Validation within pharmaceutical or biotechnology manufacturing environments.
- Strong analytical, documentation and problem-solving skills.
- Ability to manage multiple projects and collaborate effectively with cross-functional teams.
Pay: $90,000.00 – $110,000.00 per year
Work Location: In person
