Validation Specialist

2 weeks ago

Brisbane, Queensland, Australia PSC Biotech Full time

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements.

Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia-Pacific and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.


The Experience


With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers.

As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech, it's about more than just a job—it's about your career and your future.

Your Role

  • Validate GxP facilities, processes, and perform qualification of equipment is assigned projects.
  • Provide authoring, review, and approval of validation documents, ensuring that documentation meets regulatory requirements and quality standards.
  • Draft and execute validation project plan, IQ, OQ, PQ protocols, and validation summary reports.
  • Develop and manage validation studies such as cleaning validation and disinfectant validation.
  • Develop and implement validation procedures, monitor equipment, and analyze test data.
  • Establish validation standards and develop performance testing and quality control measures.
  • Collaborate with multiple departments on assigned project activities and deliverables.
  • Additional duties may be assigned from time to time.

Requirements:

  • Bachelors Degree in a relevant science or engineering field, or equivalent handson experience.
  • 3+ years of experience in the biotechnology and pharmaceutical industries with a minimum of 2 years of relevant experience performing CQV activities within GMP environment.
  • Sound industry knowledge, project proficiency, and autonomy expected.
  • Experienced in validation of facilities/utilities/equipment, including cleaning validation and IQ/OQ/PQ of equipment.
  • Strong understanding of current riskbased validation approaches.
  • Experienced in authoring, revising, reviewing, and completing controlled documents for validation projects.
  • Eperienced with risk assessments.
  • Excellent organizational skills.
  • High attention to detail.
  • Strong written and verbal communication skills.
  • Strong knowledge of the code of GMP and PIC/S code.
  • Must be adaptable, customer service oriented, and have a positive attitude.
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