Computer System Validation (CSV) Specialists | Multiple Contract Roles | Melbourne

$60-$65 per hour + Super | Staggered starts from mid-October 2026 to Q1 2027 | 6-12 month contracts

Peritus Recruitment is partnering with a leading global biotechnology leader to secure several experienced Computer System Validation (CSV) Specialists for contract roles at their Melbourne manufacturing site. Start dates run from mid-October 2026 through to Q1 2027, and contracts are between 6 and 12 months.

In these roles you'll support the validation and ongoing compliance of GMP computerised systems across manufacturing, quality and laboratory operations. A fantastic chance to build CSV experience inside a large, well-regarded global organisation.

If you've worked in validation, quality or technical roles in a GMP-regulated environment and want to grow in CSV, we'd like to hear from you.

Key Responsibilities

- Plan, write and execute CSV lifecycle documents, including validation plans, risk assessments, URS/FS, IQ/OQ/PQ protocols, traceability matrices and summary reports

- Validate new and upgraded GMP computerised systems, such as MES, LIMS, eBR, SCADA/DCS,



QMS platforms and lab instrument software

- Assess and document changes to validated systems through change control, making sure systems stay in a validated state

- Carry out periodic reviews, audit trail reviews and data integrity assessments

- Support deviations, CAPAs and investigations that involve computerised systems

- Work with system owners, IT, Quality Assurance and Engineering to deliver validation on schedule

- Support internal audits and regulatory inspections as needed

About You

- A tertiary qualification in science, engineering, IT or a related discipline

- Experience in a GMP-regulated pharmaceutical, biotechnology or medical device environment

- Hands-on experience with computer system validation, or equipment and process validation with a strong interest in moving into CSV

- Working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and data integrity (ALCOA+) principles

- Strong technical writing skills and close attention to detail in GMP documentation

📌 CSV Specialist (Melbourne)
🏢 Peritus Recruitment
📍 Melbourne