Biotechnology Validation Specialist

4 days ago


Brisbane, Queensland, Australia beBeeValidation Full time $90,000 - $120,000
Job Overview

We are seeking a skilled Biotechnology Validation Specialist to join our team in a dynamic biotechnology landscape.

Key Responsibilities
  • Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
  • Responsible for protocol writing and execution: draft, execute, review, and approve validation documentation ensuring it meets cGMP requirements, regulatory requirements, and quality standards.
  • Draft and execute validation documentation, including:
    • Validation Project & Master Plans
    • Requirement Specifications (URS, DS, FS)
    • IQ and OQ Test Scripts
    • IQ/OQ/PQ Protocols
    • Validation Summary Report
  • Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
  • Conduct preventative maintenance and perform risk assessments.
  • Recommend process improvements where needed to ensure compliance with industry standards.
  • Establish validation standards and develop performance testing and quality control measures.
  • Execute process equipment and clean room validation.
  • Closely collaborate with multiple departments on assigned project activities and deliverables.
Requirements
  • A degree in a relevant field of study or equivalent experience.
  • Extensive knowledge of validation principles, regulations, and industry standards.
  • Excellent communication and project management skills.
  • Familiarity with laboratory and quality control procedures.
What We Offer
  • A competitive compensation package that rewards your hard work and dedication.
  • A comprehensive benefits structure that supports your well-being and career growth.
  • Ongoing training and development opportunities to help you advance in your profession.
About Our Company

We are a leading provider of life sciences services, dedicated to helping clients succeed in the healthcare industry.



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