Job Description
Computer System Validation (CSV) Specialists | Multiple Contract Roles | Melbourne n
$60-$65 per hour + Super | Staggered starts from mid-October **** to Q****** | 6-12 month contracts
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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.
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In these roles you'll support the validation and ongoing compliance of GMP computerised systems across manufacturing, quality and laboratory operations. A fantastic prospect to build CSV experience inside a large, well-regarded global organisation.
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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 n
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Plan, write and execute CSV lifecycle documents, including validation plans, risk assessments, URS/FS, IQ/OQ/PQ protocols, traceability matrices and summary reports
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Validate new and upgraded GMP computerised systems, such as MES, LIMS, eBR, SCADA/DCS,



QMS platforms and lab instrument software
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Assess and document changes to validated systems through change control, making sure systems stay in a validated state
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Carry out periodic reviews, audit trail reviews and data integrity assessmentsSupport deviations, CAPAs and investigations that involve computerised systems
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Work with system owners, IT, Quality Assurance and Engineering to deliver validation on schedule
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Support internal audits and regulatory inspections as needed
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About You n
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A tertiary qualification in science, engineering, IT or a related discipline
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Experience in a GMP-regulated pharmaceutical, biotechnology or medical device environment
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Hands-on experience with computer system validation, or equipment and process validation with a strong interest in moving into CSV
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Working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and data integrity (ALCOA+) principles
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Strong technical writing skills and close attention to detail in GMP documentation
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📌 Csv Specialist (Melbourne)
🏢 Peritus Recruitment
📍 Melbourne