Commissioning Qualification Validation Specialist

2 months ago

Sydney, New South Wales, Australia PSC Biotech Corporation Full time

About the Role

PSC Biotech Corporation is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our facilities, equipment, and utilities.

Key Responsibilities

  • Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
  • Develop and execute validation protocols, including IQ and OQ test scripts, and validation summary reports.
  • Conduct risk assessments, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
  • Perform preventative maintenance and conduct 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 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.

About PSC Biotech Corporation

PSC Biotech Corporation is a global leader in providing essential services to the life sciences industry. We are committed to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of health care products.

Equal Opportunity Employment Statement

PSC Biotech Corporation is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer-sponsored activities and programs.

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