Computer System Validation (CSV) Specialist
Computer System Validation (CSV) Specialist
Posted on :
26-08-2025
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1 Vacancy
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Job Description
CAI is looking for individuals with arangeof experiencein the areas of commissioning qualification and validation to join ourteam in 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 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 clients 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 persons success is everyones 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 Australias 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 include:
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.
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
Youll join a values-driven team pushing the boundaries in therapeutic manufacturing with plenty of room to grow innovate and shape the future of health.
#LI-JD1
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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