Raw Materials Engineer, MSAT

Avid Bioservices•Tustin, CA

2d•Onsite

About The Position

The Raw Materials Engineer, MSAT provides day-to-day technical management, qualification, implementation, monitoring, and support of raw materials, consumables, and single-use components used across Avid's manufacturing processes. The role exists to ensure that materials are technically suitable, qualified, and ready to support technology transfers, engineering runs, PPQ campaigns, and commercial manufacturing. Its scope spans new material introduction and qualification, specification authoring and support, supplier technical support, BOM assessment and material readiness during technology transfer, and technical support to material-related investigations. It partners closely with Supply Chain, Quality, Process Development, Validation, and Program Management, and serves as the operational execution arm of Raw Material Lifecycle Management activities at the site. Working under the technical direction of MSAT leadership, the role executes assigned material activities with limited day-to-day oversight, prepares technical assessments and specifications for MSAT and Quality review, and escalates material risks to MSAT leadership.

Requirements

Bachelor's degree in Engineering, Biotechnology, Biology, Biochemistry, Pharmaceutical Sciences, or related field, or equivalent experience).
3 - 5 years of experience supporting biologics manufacturing, MSAT, process development, quality, supply chain, or manufacturing operations.
A team player who can oversee a project from start to finish with little to no supervision.
Understanding of GMP manufacturing environments and technical documentation expectations.

Nice To Haves

Experience supporting raw material technical assessments, investigations, change controls, or material qualification activities, and ability to work cross-functionally across multiple program priorities.
Experience with supplier management and supplier technical documentation.
Experience with raw material specifications, single-use technologies, resins, filters, or consumables.
New product introduction, technology transfer, PPQ support, or CDMO manufacturing experience.
Experience with deviations, investigations, CAPAs, or manufacturing troubleshooting.

Responsibilities

Qualify and implement new raw materials, consumables, and single-use components with Supply Chain, QA, QC, and Manufacturing, so that materials are GMP-ready ahead of technology transfers, engineering runs, PPQ campaigns, and commercial production.
Build qualification packages and technical assessments for assigned materials, so that material readiness is documented per cGMP requirements.
Author and revise Raw Material Specifications with MSAT, QA, QC, and Supply Chain, collaborating with clients on material requirements, so that acceptance criteria stay aligned with process requirements, client requests and supplier capability.
Serve as day-to-day technical contact for assigned suppliers, reviewing their documentation, change notifications, and performance data, so that supplier technical risk stays visible and documented.
Engage clients directly by email on raw material topics, collaborating on BOM assessments and Raw Material Specifications with Program Management leading client meetings, so that client material requirements are captured in Avid documentation.
Perform raw material gap and BOM assessments during technology transfer, so that implementation gaps are resolved before manufacturing needs the materials for production.
Drive material readiness actions across PPQ campaigns, so that material issues do not delay PPQ execution.
Assess supplier changes, material substitutions, specification revisions, and supply disruptions, so that approved changes are implemented with complete, inspection-ready documentation.
Support material-related Quality Events, and CAPAs with Manufacturing, Supply Chain and Quality Assurance and Quality Control, so that material issues are resolved with minimal manufacturing impact.
Manage assigned materials from onboarding through periodic review, requalification, and retirement, so that technical files and lifecycle records stay current.