Computer Systems Validation Specialist

ProClinical; Sydney; On-site; AUD 120,000 - 170,000; Full time

Job summary

Proclinical is seeking a Computer System Validation (CSV) Specialist to join a pioneering biologics manufacturer in Australia, focusing on validation of regulated computerised systems for GMP operations.

Reporting to the Validation Manager, you will plan, execute, and document CSV activities (IQ, OQ, PQ) and ensure data integrity, audit readiness, and change control across ERP, LIMS, QMS, and other GxP systems.

Qualifications

• Bachelor’s degree in a relevant field and experience in CSV within regulated environments.
• Experience validating software and systems used in GxP operations.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and data integrity.

Responsibilities

• Develop and execute CSV protocols (IQ, OQ, PQ) for regulated systems.
• Create and review Validation Plans, Risk Assessments, and Traceability Matrices.
• Ensure compliance with GxP, FDA Part 11, and EU Annex 11 across systems.
• Provide CSV documentation guidance and support audit readiness.
• Collaborate with IT, QC, QA, and Engineering to align validation with requirements.
• Train staff on CSV procedures and drive continuous improvement.

Skills

CSV validation

GxP knowledge

Regulatory compliance

Dokument writing

Cross-functional collaboration

IQ/OQ/PQ

Data integrity

Audit readiness

Change control

SOP development

Education

Bachelor’s degree in computer science, life sciences, engineering, QA

Tools

ERP

LIMS

QMS

GxP systems

Job description

Proclinical is seeking a Computer System Validation (CSV) Specialist to join our client, a pioneering biologics manufacturer establishing one of Australia’s first commercial facilities dedicated to end-to-end viral vector production for advanced therapies. Uniquely embedded within a major health, education, research, and innovation precinct, our client is positioning itself as a leading CDMO in the Asia–Pacific region.

As the organisation continues to scale toward full commercial operations, this role will be central to ensuring computerised systems used across regulated environments are validated and maintained in compliance with applicable regulatory requirements, while supporting data integrity, system reliability, and inspection readiness.

Why this role?

This is a rare opportunity to join a first-of-its-kind advanced therapies manufacturing facility in Australia and play a key role in building and maintaining compliant, audit-ready digital systems that support GMP operations.

You will have the chance to work across a broad range of regulated systems and partner closely with cross-functional stakeholders to shape validation strategy, strengthen compliance, and support the successful implementation and lifecycle management of computerised systems within a highly innovative manufacturing environment.

Role Overview

Reporting to the Validation Manager, the Computer System Validation (CSV) Specialist will be responsible for ensuring that all computerised systems used in regulated environments are validated in compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

This role focuses on planning, executing, and documenting validation activities for software and systems used in GxP processes, ensuring data integrity, system reliability, and compliance. You will act as a key technical SME for CSV documentation requirements and validation approaches, while supporting audit readiness and change control across computerised systems.

Working cross-functionally with IT, QC and QA and Engineering, you will help ensure systems meet both user and regulatory requirements, while contributing to the broader data integrity and quality culture of the organisation.

Key Responsibilities

Computer System Validation

• Develop and execute CSV protocols including IQ, OQ, and PQ
• Author and review validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Ensure systems are validated in accordance with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable requirements
• Provide technical guidance on CSV documentation requirements and validation approaches
• Maintain accountability for computerised system change control
• Support audit readiness and provide CSV support during inspections and audit activities

Regulatory Compliance & Data Integrity

• Support compliance with relevant regulations, legislation, and standards
• Contribute to the company’s Data Integrity program
• Help ensure electronic systems are maintained in a compliant and controlled state throughout their lifecycle

Cross-Functional Collaboration

• Partner with stakeholders across IT, QC, and business teams to ensure systems meet business, user, and regulatory requirements
• Support validation activities associated with software and equipment used in regulated environments
• Assist with broader project work to ensure validation requirements are delivered within agreed timeframes and standards

Training & Continuous Improvement

• Train employees on CSV procedures and regulatory expectations
• Foster a culture of quality through mentoring and education
• Identify continuous improvement opportunities and implement solutions to strengthen systems and validation processes

Skills & Experience

• Bachelor’s degree in computer science, life sciences, engineering, quality assurance, or a related discipline
• Demonstrated experience in computer system validation within a regulated industry such as pharmaceutical, biotech, or medical device
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and data integrity principles
• Understanding of TGA and other relevant regulatory guidelines supporting cGMP compliance
• Experience validating software associated with equipment and regulated operations
• Experience with ERP, LIMS, QMS, or other GxP systems is advantageous
• Familiarity with business continuity and disaster recovery risk planning relating to electronic systems
• Strong document writing, communication, analytical, and problem-solving skills
• Ability to manage multiple priorities and work effectively across functions
• Positive, proactive, solutions-focused mindset with strong professionalism and team orientation
• Willingness to support operational requirements as needed, including occasional work outside standard business hours

Desirable

• Understanding of software development tools and languages
• Understanding of databases

Proclinical Staffing is an equal opportunity employer.