Validation Specialist

6 days ago

Melbourne, Victoria, Australia beBeeValidation Full time $180,000 - $200,000
Senior Commissioning, Qualification, and Validation Engineer Opportunity

The Senior Commissioning, Qualification, and Validation (CQV) Engineer is responsible for ensuring that systems, facilities, and equipment meet design requirements.

  • Act as a lead and simplify CQV functions, reports, and processes to enhance efficiency.
  • Support the implementation of safety programs for major capital projects, promoting a culture of safety.
  • Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects, ensuring compliance with regulatory requirements.
  • Initiate, author, revise, review, and complete controlled documents for CQV projects, maintaining accuracy and consistency.
  • Review and qualify equipment for commissioning, qualification, and validation activities, ensuring that only approved equipment is used.
  • Write and review GMP and GDP documents and technical specifications, providing clarity and precision.
  • Collaborate with multiple departments on assigned project activities and deliverables, fostering effective communication.
  • Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ, ensuring that risks are identified and mitigated.
  • Contact and work with contractors and vendors on assigned projects, building strong relationships.
Requirements and Qualifications
  • Bachelor's Degree in Engineering or Life Science, with a strong foundation in relevant principles and practices.
  • 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry, with a proven track record of success.
  • Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents, demonstrating expertise.
  • Proficient in developing SOPs, final reports, and validation & quality policies, ensuring compliance and adherence.
  • Strong experience developing and executing CQV protocols, with a focus on quality and efficacy.
  • Strong experience creating and maintaining CQV policies and processes, promoting continuous improvement.
  • Good understanding and compliance with cGMPs and CFR21 Part 11 guidelines, ensuring regulatory compliance.
  • Demonstrated strategic thinking and implementation skills, with the ability to translate data into actionable plans.
  • Excellent presentation and communication skills, both written and oral, for a variety of audiences.
  • Highly organized in planning and time management, with the ability to multi-task and prioritize effectively.
Why This Role Matters

This role plays a critical part in ensuring the quality and safety of our products and services. If you are passionate about delivering high-quality results and driving excellence, we encourage you to apply.

What We Offer

We offer a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.

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