Commissioning Qualification Validation Specialist

4 weeks ago


Adelaide, South Australia PSC Biotech Full time
Job Title: Commissioning Qualification Validation EngineerAbout PSC Biotech

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. Our global team of experts spans across strategically located offices, and we take pride in our ability to deliver exceptional results for our clients.

The Role

We are seeking a highly skilled Commissioning Qualification Validation Engineer to join our team. As a key member of our CQV team, you will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects. Your expertise will be instrumental in ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
  • Develop and execute validation protocols, ensuring compliance with cGMP requirements and regulatory standards.
  • Conduct risk assessments, design reviews, and execute FAT/SAT, IQ, OQ, and PQ activities.
  • Perform preventative maintenance and risk assessments, and recommend process improvements where necessary.
  • Establish validation standards and develop performance testing and quality control measures.
  • Collaborate with multiple departments on assigned project activities and deliverables.
Requirements
  • Bachelor's Degree in a relevant science or engineering field, or equivalent 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.
  • Understands current risk-based validation approaches.
  • Excellent organizational skills, high attention to detail, and strong written and verbal communication skills.
What We Offer

PSC Biotech offers a competitive compensation and benefits package, as well as opportunities for growth and development. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply for this exciting opportunity.



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