Validation and Commissioning Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeecqv Full time $100,000 - $150,000
Commissioning and Validation Expert

We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team.

  • Key Responsibilities:
    • Plan and execute the commissioning, qualification, and validation of GxP facilities, equipment, and utilities in assigned projects.
    • Create and review validation documentation ensuring it meets cGMP requirements, regulatory needs, and quality standards.
    • Develop and execute validation protocols for various systems, including IQ/OQ/PQ, risk analyses, design reviews, and FAT/SAT.
    • Conduct preventative maintenance, perform risk assessments, and implement process improvements where needed.
    • Establish validation standards and develop performance testing and quality control measures.
  • Requirements:
    • Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
    • 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environments.
    • Proven industry knowledge, project proficiency, and autonomy expected.
    • Experience with system impact assessment, risk assessment, and cGMP compliance.
    • Familiarity with PIC/S code and previous experience in GxP Industries is required.
    • Strong communication, organizational, and analytical skills are essential.

About the Role

This is an exciting opportunity to work on challenging projects and contribute to the success of our organization. If you have a passion for commissioning, qualification, and validation, and a strong desire to grow your career, we encourage you to apply.

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