DescriptionLooking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role: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.
Key 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.
Minimum Qualifications:- 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.
Preferred Qualifications: - 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.
Position Type/Expected Hours of Work: This role is a full-time onsite position in Tustin, CA. Days of work are Monday through Friday. The employee must also, if instructed, have the ability to work overtime, weekends and/or holidays when necessary.
Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $95,200 to $119,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are: - You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
