Equipment Qualification Engineer

3 days ago


Irvine, California, United States PSC Biotech Full time

PSC Biotech is a renowned provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the industry. As an experienced Validation Engineer, you will play a crucial role in supporting our clients' success by executing equipment commissioning, qualification, and validation projects.

About the Role

This position requires a highly motivated individual with a Bachelor's degree in a related engineering discipline and a minimum of 3 years of experience executing equipment commissioning, qualification, and validation within the pharmaceutical and/or biotechnology industries. You should possess strong knowledge of regulatory requirements (cGMP, FDA, etc.) and excellent technical writing skills and knowledge of full lifecycle validation documentation.

  • This role involves leading the development and execution of commissioning, qualification, and validation protocols for plant equipment.
  • You will draft, review, author, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and so on.
  • As a technical expert, you will provide guidance throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.

We offer a dynamic and supportive work environment, with a competitive salary range of $80,000 - $100,000 per year, depending on experience. Our comprehensive benefits package includes medical, dental, and vision insurance, as well as 401(k) matching and education assistance.


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