Biotechnology Validation Specialist

5 days ago

Sydney, New South Wales, Australia beBeeCqv Full time $120,000 - $150,000
CQV Professional - Biotechnology Landscape

The role involves commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects. This includes writing and executing validation protocols, as well as drafting and approving validation documentation to meet regulatory requirements.

This is a challenging opportunity for a skilled CQV professional to take on a leading role in the biotechnology landscape. The successful candidate will have a strong background in commissioning, qualification, and validation, as well as excellent communication and project management skills.

  • Key Responsibilities:
  • Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
  • Draft and execute validation protocols, including IQ/OQ/PQ test scripts and validation summary reports.
  • Coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ activities.
  • Conduct preventative maintenance and perform risk assessments.
  • Develop performance testing and quality control measures.
  • Execute process equipment and clean room validation.
  • Collaborate with multiple departments on assigned project activities and deliverables.

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 regulated environments.
  • Sound industry knowledge, project proficiency, and autonomy expected.
  • Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
  • Good knowledge of regulatory codes and standards.

About the Role:

The ideal candidate will possess strong technical expertise, leadership skills, and the ability to work collaboratively across teams. They will be responsible for ensuring that all projects are completed on time, within budget, and to the highest standards of quality.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for career growth and development. If you are a motivated and experienced CQV professional looking for a new challenge, please apply today.

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