Computer System Validation (CSV) Specialist

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 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.  ·       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.   #LI-JD1