CSV Engineer

Job Capital Pty Ltd as Trustee for Job Capital Uni; Sydney; On-site; AUD 120,000 - 170,000; Full time

Job summary

Job Capital Pty Ltd as Trustee for Job Capital Uni is seeking a Computer System Validation (CSV) Engineer to support GMP-regulated automation and data systems in pharmaceutical/biotech manufacturing environments. Responsibilities include creating IQ/OQ tests, risk assessments and validation reports, and ensuring data integrity per ALCOA+.

The role requires a Bachelor’s degree and demonstrated CSV experience in pharma/biotech settings, with strong analytical and cross-team collaboration skills.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Automation, or related field.
• Experience in CSV within pharmaceutical/biotech manufacturing.
• Strong analytical and documentation skills.
• Ability to manage multiple projects and cross-functional teams.

Responsibilities

• Own and deliver CSV activities for GMP automation and data systems.
• Develop and execute validation documentation per GAMP 5, Annex 11, and 21 CFR Part 11.
• Prepare, review and execute CSV documentation and testing.
• Review and approve validation documentation for quality and data integrity.
• Coordinate with cross-functional teams for GMP and regulatory compliance.
• Support commissioning and qualification activities (SAT and FAT).
• Implement formal change control procedures for automation changes.
• Provide technical support for automation systems and troubleshoot issues.
• Maintain validation records and ensure ALCOA+ data integrity.

Skills

CSV engineering

GAMP 5

QA documentation

Education

Bachelor's degree in Engineering, Biotechnology or Automation

Tools

IQ

OQ

SAT

FAT

Job description

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 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.