Raw Materials Engineer, MSAT
Listed on 2026-10-15
-
Manufacturing / Production
Quality Engineering, Validation Engineer, Manufacturing Engineer
Raw Materials Engineer, MSAT | Tustin, CA
Location: Tustin, CA
Schedule: Monday–Friday | Onsite
Are you an engineer or life sciences professional with experience in biologics manufacturing, MSAT, process development, or quality
?
Join a leading biologics CDMO supporting the development and manufacturing of life-saving therapies.
About the RoleThe Raw Materials Engineer, MSAT will play a key role in ensuring raw materials, consumables, and single-use components are qualified, technically suitable, and ready to support manufacturing operations
.
You’ll work cross-functionally with MSAT, Quality, Supply Chain, Manufacturing, Process Development, Validation, and Program Management
, supporting materials from introduction and qualification through technology transfer, PPQ, commercial manufacturing, and lifecycle management.
- Qualify and implement raw materials, consumables, and single-use components
- Develop technical assessments and qualification packages
- Author and revise Raw Material Specifications
- Support BOM assessments and technology transfers
- Manage technical relationships with suppliers and clients
- Assess supplier changes, substitutions, specifications, and supply risks
- Support deviations, investigations, Quality Events, and CAPAs
- Drive material readiness for engineering runs, PPQ, and commercial manufacturing
- Manage materials throughout their lifecycle
, from onboarding to retirement
Required:
- Bachelor's degree in Engineering, Biotechnology, Biology, Biochemistry, Pharmaceutical Sciences
, or related field - 3–5 years of experience in biologics manufacturing, MSAT, process development, quality, supply chain, or manufacturing operations
- Understanding of GMP manufacturing and technical documentation
- Ability to independently manage projects and work cross-functionally
- Raw material qualification or technical assessment experience
- Supplier management and technical documentation
- Experience with single-use technologies, resins, filters, or consumables
- Technology transfer, PPQ, NPI, or CDMO experience
- Experience with deviations, investigations, CAPAs, or manufacturing troubleshooting
Competitive hourly compensation
Performance-based bonuses
401(k) matching
Paid time off
Career growth and development opportunities
Work Authorization:Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
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