MSAT Raw Materials Engineer — Biologics Manufacturing

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

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.