Biotechnology Validation Engineer

3 days ago

Sydney, New South Wales, Australia beBeeQualification Full time $120,000 - $200,000
Job Description

We are seeking a Commissioning, Qualification, and Validation (CQV) Professional to undertake commissioning, qualification, and validation of facilities, equipment, and utilities in assigned projects.

The CQV Professional will work alongside a talented team in an exciting, developing, and diverse 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 the documentation meets cGMP requirements, regulatory requirements, and quality standards.
  • Draft and execute validation documentation such as:
    • 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.
  • Recommended process improvements where needed ensuring compliance with industry standards.
  • Establish validation standards and develop performance testing and quality control measures.
  • Execute process equipment and clean room validation.
  • Clearly communicate all progress, updates, and action steps for assigned projects. 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 GMP environment.
  • Sound industry knowledge, project proficiency, and autonomy expected.
  • Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
  • Understands current risk-based validation approaches.
  • Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
  • Experience with system impact assessment and risk assessment.
  • Good knowledge of the code of GMP and PIC/S code.
  • Previous experience in the Life Sciences Industry is required.
  • Previous experience in GxP Industries are required.
  • Must be adaptable, customer service oriented, have a positive attitude.
  • Excellent organizational skills.
  • High attention to detail.
  • Must have strong written and verbal communication skills.

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