Engineer Raw Materials , MSAT

🚀 Engineer Raw Materials, MSAT

📍 Tustin, CA | On-site

🗓 Monday–Friday | Full-Time

🌱 Support the Manufacturing of Life-Saving Biopharmaceuticals

🎓 Ideal opportunity for biologics manufacturing, MSAT, quality, supply chain, and process development professionals with experience supporting raw materials and manufacturing operations.

Are you passionate about raw materials, technology transfer, process support, and manufacturing readiness ? We're looking for a Raw Materials Engineer, MSAT to support the qualification, implementation, monitoring, and lifecycle management of raw materials, consumables, and single-use components used across biologics manufacturing processes.

🔬 What You'll Do

✔ Qualify and implement new raw materials, consumables, and single-use components to support manufacturing readiness

✔ Build material qualification packages and technical assessments to ensure GMP compliance and documentation readiness

✔ Author and revise Raw Material Specifications in partnership with MSAT, QA, QC, Supply Chain, and clients

✔ Serve as a technical contact for suppliers, supporting change notifications, documentation reviews, and supplier performance assessments

✔ Perform BOM reviews and raw material gap assessments during technology transfer activities

✔ Drive material readiness activities supporting engineering runs, PPQ campaigns, and commercial manufacturing

✔ Support material-related investigations, quality events, deviations, CAPAs, and supplier changes

✔ Manage materials throughout their lifecycle, including onboarding, qualification, periodic review, requalification, and retirement

✅ What We're Looking For

🎓 Bachelor's degree in Engineering, Biotechnology, Biology, Biochemistry, Pharmaceutical Sciences, or a related field (or equivalent experience)

🧪 3-5 years of experience supporting biologics manufacturing, MSAT, process development, quality, supply chain, or manufacturing operations

🧪 Understanding of GMP manufacturing environments and technical documentation expectations

🧪 Ability to independently manage projects and collaborate cross-functionally in a fast-paced environment

💰 Compensation

Base Salary: $95,200 - $119,000 annually

✅ Additional compensation and benefits package available

📍 Please Note

✅ On-site in Tustin, CA

✅ Full-time position supporting MSAT and manufacturing operations

✅ Schedule is Monday through Friday

✅ Overtime, weekend, and holiday support may be required based on business needs

🚫 No relocation assistance mentioned

🚫 No visa sponsorship information provided

If this sounds like you, or someone in your network, I'd love to connect!

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