Computer System Validation
vor 3 Wochen
Computer System Validation (CSV) Specialist Sydney / Australia / Full Time CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required. About CAI CAI is a 100% employee‑owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start‑up, project management and consulting services related to operational readiness to FDA regulated and other mission‑critical industries. Are You Ready? Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: We act with integrity We serve each other We serve society We work for our future With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can‑do attitude. That is how we have grown exponentially. CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services. About the Role We are seeking a hands‑on, experienced Computer System Validation (CSV) Specialist to join a cutting‑edge advanced therapeutics facility based in Australia’s largest health, education, research, and innovation precinct. This full‑time opportunity is ideal for someone with a strong background in CSV within GxP environments, looking to make a meaningful impact in a high‑growth, high‑integrity setting. Work Location: Sydney, Australia Employment Type: Full Time Employee Requirements 3+ years’ experience in CSV in pharma, biotech, or medical devices. Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks. Experience validating ERP, LIMS, QMS, or equipment‑related software. Detail‑oriented, analytical, and proactive team player. Comfortable working flexibly to meet production schedules. Australia/New Zealand PR or Citizen Position Requirements Lead validation activities (IQ/OQ/PQ) across GxP‑regulated systems. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5. Partner with IT, QC, and business teams to meet user and regulatory needs. Author and review validation plans, risk assessments, and traceability matrices. Contribute to data integrity programs and support audits. Train staff and promote a quality‑focused culture. Why Join? You’ll join a values‑driven team pushing the boundaries in therapeutic manufacturing — with plenty of room to grow, innovate, and shape the future of health. #J-18808-Ljbffr
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Computer System Validation
Vor 3 Tagen
Council of the City of Sydney, Österreich Commissioning Agents Inc VollzeitCAI is looking for individuals with arangeof experiencein the areas of commissioning, qualification, and validation to join ourteam in Australia.Experience in the pharmaceutical, medical deviceor biotechnologyindustries is required. About CAI : CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people...
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Computer Systems Validation
vor 23 Stunden
City of Brisbane, Österreich PSC Biotech Corporation VollzeitJob Description The Computer Systems Validation Engineer (CSV) will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The incumbent is also responsible and...
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Computer Systems Validation
Vor 5 Tagen
City of Melbourne, Österreich PSC Biotech VollzeitMelbourne, Australia | Posted on 10/17/2025 We are looking for a Computer Systems Validation (CSV) Engineer to join our team on a 12-month contract . The CSV Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based...
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Computer Systems Validation
vor 2 Wochen
City of Brisbane, Österreich PSC Biotech VollzeitBrisbane, Australia | Posted on 12/06/2024 The Computer Systems Validation Engineer (CSV) will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The...
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Computer Systems Validation
Vor 3 Tagen
City of Brisbane, Österreich PSC Biotech VollzeitBrisbane, Australia | Posted on 10/17/2025 We are looking for a Computer Systems Validation (CSV) Engineer to join our team on a 12-month contract . The CSV Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based...
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CSV Specialist — Lead GxP Validation
Vor 3 Tagen
Council of the City of Sydney, Österreich Commissioning Agents Inc VollzeitA leading consulting firm is seeking a Computer System Validation (CSV) Specialist to join their team in Sydney, Australia. The role involves leading validation activities, ensuring compliance with regulatory standards, and working collaboratively with cross-functional teams. Candidates should have 3+ years of experience in CSV within GxP environments and a...
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Verification and Validation Engineer
Vor 3 Tagen
City of Melbourne, Österreich L3Harris Technologies VollzeitVerification and Validation Engineer Join L3Harris Technologies as a Verification and Validation Engineer in Melbourne, VIC, supporting the Airservices Australia Enterprise Network Modernization Program. Roles & Responsibilities Develop System Level Test Plans, System Test Procedures and other required System test documents. Execute or supervise System test...
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Computer Network and System Engineer
vor 3 Wochen
City of Melbourne, Österreich Labour Support Group VollzeitComputer Network and System Engineer (LSG.LID.CNSE.E.VIC) Epping, Melbourne, Australia Salary: AUD85000 - AUD90000 per annum The Client: IGroup Consulting is an IT Consulting Systems Integration firm that delivers comprehensive IT services to leading clients in Australia. They are a full IT solutions provider offering expertise across Financial Services,...
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City of Melbourne, Österreich L3Harris Technologies VollzeitA leading technology company is looking for a Verification and Validation Engineer to support the Airservices Australia Enterprise Network Modernization Program in Melbourne, VIC. The role involves developing testing plans, executing system tests, and coordinating with various leads. Candidates should hold a degree in Computer Science or a related field and...
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Verification and Validation Engineer
vor 4 Wochen
City of Melbourne, Österreich Harris Geospatial Solutions VollzeitL3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers’ mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our...
