Regulated Products Validation Engineer

1 day ago


San Jose, California, United States MILLENNIUMSOFT Full time
About the Job

MILLENNIUMSOFT is seeking a Regulated Products Validation Engineer to join our team in San Jose, CA.

The estimated annual salary for this position is $140,000 - $200,000 based on industry standards and location.

About the Role:

We are looking for an experienced professional to lead the development and validation of QC test methods and manufacturing processes.

As a Regulated Products Validation Engineer, you will prepare and submit SOPs, WI's, BOMs, routings, and standard costing for new products into SAP.

Responsibilities:

  • Develop, scale up, and set up manufacturing processes to optimize process flow, reduce variability, and improve operating capabilities.
  • Work with R&D teams to develop and validate QC test methods.
  • Prepare and submit regulatory documents, including protocols and reports.
  • Promote a safe work environment.

Requirements:

  • Bachelor's degree in biological sciences or related field with 5 years of relevant experience or Master's degree with minimum of 3 years of relevant experience.
  • At least 3 years of experience in a FDA or ISO regulated medical device production environment.
  • Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed.
  • SAP experience is highly preferred.

Benefits:

  • Competitive salary range: $140,000 - $200,000 per year.
  • Ongoing training and development opportunities.
  • A collaborative and dynamic work environment.


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