Computer System Validation (CSV) Specialists | Multiple Contract Roles | Melbourne
$60-$65 per hour + Super | Staggered starts from mid-October **** to Q****** | 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 **** through to Q******, 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 opportunity 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 workplace 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 assessmentsSupport 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
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📌 Csv Specialist (Melbourne)
🏢 Peritus Recruitment
📍 Melbourne