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

✅ Health, dental & vision insurance

✅ 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

f you have experience connecting technical materials management with GMP manufacturing , I'd love to hear from you!

📩 Interested or know someone who may be a great fit? Send me a message or apply today.

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The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,

Apply, and please feel free to reach out.

If you're passionate about biopharmaceutical manufacturing, employee development, and building a strong GMP culture , I'd love to connect!