Senior Supplier Quality Engineer
NVIDIA
Senior Engineer, MSAT
Nucleus Biologics
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $90,000 - $110,000 per year
Job Level
Senior
About the role
- Tech Transfer and onboarding of incoming upstream projects (including Process Performance Validations, Technical Design for Validations, and product FMEAs)
- Drive Core Product Development Initiatives and scale up
- Develop and Review manufacturing Batch Records
- Generate and execute process development studies and technical documentation base on results
- Drive pilot test runs in preparation for onboarding projects
- Develop and improve current and new manufacturing processes
- Work with software engineers to develop automated systems
- Support Project management group with technical support and communication during customer onboarding
- Facilitate clear communication with cross-functional Core Team and stakeholders
- Support integration of regulatory requirements during product commercialization
- Collect and generate data to support analysis for strategic upstream decision making
- Rapid TAT for evaluating onboarding of new projects during feasibility
- Report to Associate Director, MSAT
- Have fun and contribute to a winning culture
Requirements
- Requires a BS or MS degree in Chemistry, Biochemistry, Organic Chemistry, Chemical Engineering or related field
- BS degree: 4+ years of related experience
- MS degree: 3+ years of related experience
- Must thrive in a fast paced, start-up environment and must be able to meet critical deadlines
- Previous work experience in life science, pharma or biotech industries preferred
- Ability to self-manage multiple projects and priorities simultaneously
- Previous experience with new product introduction and commercialization
- Development of SOPs, BRs, WI
- Strong fundamental knowledge in chemistry
- Hands-on experience handling lab equipment, mixers, pH meter, Osmometer, conductivity meters
- Proficient in understanding Good Manufacturing Practices (GMP) and how GMP applies to the development of a process
- Intermediate to advanced skills in Word, Excel and PowerPoint
- Detail-oriented and process driven
- Strong Problem solving and decision making skills
- Good written and oral communication skills
- General understanding of software systems and AI language models is a plus
- Familiarity with ISO 13485 a plus
- Ability to hear and speak to employees and external associates on the phone and in person
- Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
- Ability to lift 30 lbs. to a height of 3-4 feet on a regular basis
- May require travel to and from Nucleus Biologics offices or customer/vendor locations
