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Process Validation Specialist

1 month ago

San Jose, California, United States MILLENNIUMSOFT Full time
Job Title: Process Validation Engineer

Job Summary:

We are seeking a highly skilled Process Validation Engineer to join our team at MillenniumSoft. As a Process Validation Engineer, you will be responsible for developing, scaling up, and validating manufacturing processes to optimize process flow, reduce variability, and improve operating capabilities.

Key Responsibilities:

  • Develop and validate manufacturing processes to ensure compliance with regulatory requirements.
  • Work with R&D team to develop and validate QC test methods.
  • Prepare and submit SOPs, WIs, BOMs, routings, and standard costing for new products into SAP.
  • Design, write, and execute Gage R&R, scale-up, stability, and validation studies and associated reports.
  • Promote a safe work environment.

Requirements:

  • Bachelor's degree in biological sciences with 5 years of relevant experience or Master's degree with minimum of 3 years of relevant experience.
  • Minimum of 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.
  • Experience in developing manufacturing processes and QC test methods is a must.
  • Experience in document creation, BOMs, routings, etc.
  • Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
  • Experience in SAP is highly preferred.
  • Experience in statistical analysis, 6 Sigma Greenbelt or Lean Manufacturing certification preferred.

What We Offer:

MillenniumSoft offers a dynamic and challenging work environment with opportunities for professional growth and development. We are committed to providing our employees with the resources and support they need to succeed.