MSAT Raw Materials Engineer — Biologics Manufacturing

BioTalent; Tustin (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive hourly compensation

Performance-based bonuses

401(k) matching

Paid time off

Career growth and development

Job summary

BioTalent seeks a Raw Materials Engineer, MSAT in Tustin, CA to ensure raw materials, consumables, and single-use components are qualified and ready for manufacturing. You will collaborate across MSAT, Quality, Supply Chain, Manufacturing, Process Development, Validation, and Program Management.

The role requires a bachelor's degree and 3–5 years in biologics, MSAT, or related fields, with strong GMP documentation and project management skills.

Qualifications

• 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.

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.

Skills

Project management

Cross-functional collaboration

GMP knowledge

Technical documentation

Biologics manufacturing

Quality systems

Supplier management

Single-use technologies

Education

Bachelor's degree in Engineering, Biotechnology, Biology, Biochemistry, Pharmaceutical Sciences

Job description

BioTalent seeks a Raw Materials Engineer, MSAT in Tustin, CA to ensure raw materials, consumables, and single-use components are qualified and ready for manufacturing. You will collaborate across MSAT, Quality, Supply Chain, Manufacturing, Process Development, Validation, and Program Management.

The role requires a bachelor's degree and 3–5 years in biologics, MSAT, or related fields, with strong GMP documentation and project management skills.