Regulated Products Validation Engineer
1 day ago
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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