Engineer Raw Materials , MSAT

BioTalent; Tustin (CA); On-site; USD 95,000 - 119,000; Full time

Job summary

BioTalent is seeking a Raw Materials Engineer, MSAT in the United States to support qualification, implementation, monitoring, and lifecycle management of raw materials and single-use components used across biologics manufacturing processes.

The role focuses on material readiness, process support, and collaboration across MSAT, QA, QC, and Supply Chain to ensure GMP-aligned documentation and successful tech transfers. On-site in Tustin, CA, full-time with a Monday–Friday schedule.

Qualifications

• Bachelor's degree in engineering or life sciences.
• 3-5 years in biologics manufacturing or MSAT.
• Knowledge of GMP environments and documentation standards.
• Ability to manage projects independently and cross-functionally.

Responsibilities

• Qualify and implement new raw materials, consumables, and single-use components for manufacturing readiness.
• Build material qualification packages and assessments for GMP compliance and readiness.
• Author and revise Raw Material Specifications with MSAT, QA, QC, Supply Chain, and clients.
• Serve as a technical contact for suppliers, handling change notifications and supplier reviews.
• Perform BOM reviews and material gap assessments during technology transfers.
• Drive material readiness activities for engineering runs, PPQ campaigns, and commercial manufacturing.
• Support material-related investigations, quality events, deviations, CAPAs, and supplier changes.
• Manage materials lifecycle including onboarding, qualification, periodic review, requalification, and retirement.

Skills

Project management

Cross-functional collaboration

GMP knowledge

Independent project handling

Education

Bachelor's degree in engineering or life sciences

Job description

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

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