Raw Materials Engineer, MSAT

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 Role

The 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.

Key Responsibilities

• 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

What We're Looking For

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

Preferred:

• 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

We offer:

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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