Job Description

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

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Job Type: Permanent position | Full time position

Job Description n

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

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- Own and deliver Computer System Validation (CSV) activities for GMP automation and data systems.
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- Develop and execute validation documentation in accordance with GAMP 5, Annex 11 and 21 CFR
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Part 11 requirements.

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- Author and manage Installation Qualification (IQ), Operational Qualification (OQ), risk assessments, traceability matrices and validation reports.
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- Prepare, review and execute CSV documentation and testing activities for new and existing systems.
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- Review and approve validation documentation to ensure compliance with quality and data integrity requirements.
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- Conduct records review assessments and quality assurance reviews of technical documentation,



including User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS).
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- Coordinate with cross-functional teams to ensure compliance with GMP and regulatory requirements.
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- Support commissioning and qualification activities, including Site Acceptance Tests (SAT) and Factory Acceptance Tests (FAT).
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- Implement automation changes through formal change control procedures.
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- Provide technical support for automation systems and troubleshoot hardware, communications and configuration issues.
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- Maintain validation records and ensure adherence to ALCOA+ data integrity principles.
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Required Skills and Experience nn
- Bachelor's degree in Engineering, Biotechnology, Automation, or a related discipline.
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- Demonstrated experience in Computer System Validation within pharmaceutical or biotechnology manufacturing environments.
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- Solid analytical, documentation and problem-solving skills.
Ability to manage multiple projects and collaborate effectively with cross-functional teams.n

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