Senior CSV Engineer – GxP Validation Lead in Melbourne

Senior CSV Engineer – GxP Validation Lead in Melbourne

Melbourne Full-Time 90000 - 110000 $ / year (est.) On-site
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At a Glance

  • Tasks: Lead IQ/OQ/PQ activities and ensure compliance in GxP systems.
  • Company: Join a cutting-edge advanced therapeutics facility in Australia.
  • Benefits: Competitive salary, growth opportunities, and a dynamic work environment.
  • Other info: Sydney location with opportunities for professional development.
  • Why this job: Make a real impact in a high-growth, high-integrity setting.
  • Qualifications: Experience in CSV and strong collaboration skills required.

The predicted salary is between 90000 - 110000 $ per year.

CAI is seeking a hands-on CSV Specialist to join a cutting-edge advanced therapeutics facility in Australia.

The role focuses on leading IQ/OQ/PQ activities within Gx P systems, ensuring regulatory compliance, and coordinating with IT, QC and business teams to meet data integrity and validation needs.

You will author validation plans, risk assessments and traceability matrices, while training staff and supporting audits in a high-growth, high-integrity environment.

Sydney location.

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Senior CSV Engineer – GxP Validation Lead in Melbourne employer: CAI

CAI is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the advanced therapeutics sector. Located in Sydney, employees benefit from a vibrant city life while engaging in meaningful projects that drive personal and professional growth. With a strong emphasis on training and development, CAI empowers its team members to excel in their roles and contribute to impactful outcomes in GxP compliance.

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Contact Details:

CAI Recruitment Team

We think you need these skills to ace Senior CSV Engineer – GxP Validation Lead in Melbourne

CSV Expertise
GxP Compliance
IQ/OQ/PQ Activities
Regulatory Compliance
Validation Plans Authoring
Risk Assessments
Traceability Matrices