GxP Computer System Validation Specialist

Alimentiv; Victoria; On-site; AUD 69,000 - 115,000; Full time

Benefits offered by this job

Education Reimbursement

Cell Phone Allowance

Remote Work Allowance

Office setup allowance

Working while visiting program

Flexible Summer Hours

Employee referral incentive

Alimentiv Trust benefits

Mentorship program

Job summary

Alimentiv is seeking a Computer System Validation (CSV) Specialist to validate GCP-regulated systems in a regulated environment. You will partner with IT, Quality, and business teams to plan, execute, and document validation activities, driving compliance and system integrity.

The role offers broad exposure across validation strategies, documentation, and change control, with ongoing training and mentorship. This 12-month limited-term position supports our GI-focused CRO services globally.

Qualifications

• Bachelor's degree in a related field with 3–5 years of relevant experience.
• Experience validating GCP-regulated computerized systems and software in regulated industries.
• Strong understanding of quality system principles: validation, change control, training, audit readiness.

Responsibilities

• Validate computerized systems per GxP, 21 CFR Part 11, and regulatory requirements.
• Develop validation documentation: plans, scripts, traceability, reports, release docs.
• Coordinate with IT, QA, and vendors to define validation strategies and ensure delivery.
• Lead validation testing, manage defects and deviations, and ensure proper documentation.

Skills

GxP validation

SDLC familiarity

Cross-functional collaboration

Documentation

Communication skills

Education

Bachelor's degree in Computer Science/IT/Engineering

Tools

Automated testing tools

Job description

Alimentiv is seeking a Computer System Validation (CSV) Specialist to validate GCP-regulated systems in a regulated environment. You will partner with IT, Quality, and business teams to plan, execute, and document validation activities, driving compliance and system integrity.

The role offers broad exposure across validation strategies, documentation, and change control, with ongoing training and mentorship. This 12-month limited-term position supports our GI-focused CRO services globally.