Senior Process Validation Specialist

3 days ago


San Jose, California, United States MILLENNIUMSOFT Full time

Job Summary

MILLENNIUMSOFT seeks a highly skilled Senior Process Validation Specialist to join our team. This is a contract position with a 40-hour workweek and 12+ months duration.

About the Role

The successful candidate will be responsible for developing, scaling up, and validating manufacturing processes and QC test methods. They will also create new product documentation and transfer production processes to operations. The ideal candidate will have experience in process validation, QC test method validation, Gage studies, writing, executing DOE's, and troubleshooting manufacturing failures.

Key Responsibilities

  • Develop and scale up manufacturing processes to optimize process flow, reduce variability, and improve operating capabilities.
  • Work with R&D to develop and validate QC test methods.
  • Prepare and submit SOP's, WI's, BOM's, routings, and standard costing for new products into SAP.
  • Design, write, and execute Gage R&R, scale up, stability, and validation studies, along with associated reports.
  • Promote a safe work environment.

Requirements

To be considered for this role, applicants must have:

  • A Bachelor's degree in biological sciences with 5 years of relevant experience or a Master's degree with a minimum of 3 years of relevant experience.
  • A minimum of 3 years of experience in a FDA or ISO regulated medical device production environment.
  • Knowledge of antibody techniques, molecular biology techniques, instrumentation, and assays performed.
  • Experience in developing manufacturing processes and QC test methods.
  • Document creation skills, including BOMs, Routings, etc.
  • Writing protocols and reports with justification for design and acceptance criteria for regulated products.
  • SAP experience is highly preferred.
  • Statistical analysis skills, 6 Sigma Greenbelt, or Lean Manufacturing certification is preferred.

Estimated Salary: $95,000 - $120,000 per year, depending on experience and qualifications.



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