Job Capital Pty Ltd as Trustee for Job Capital Uni – Millers Point NSW

Job Type: Permanent position | Full time position

Job Description

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 settings. 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 recent 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.
Solid analytical, documentation and problem-solving skills.
Ability to manage multiple projects and collaborate effectively with cross-functional teams.
J-18808-Ljbffr

📌 Csv Engineer Sydney (Australia)
🏢 Job Capitalas Trustee for Job Capital Uni
📍 Australia