Avid Bioservices · 2 days ago
Associate Engineer, MSAT (Downstream)
Tustin, CA
Full-time
Onsite
Entry Level
$66K/yr - $88K/yr
1+ years expAvid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of clients and improve patient outcomes. The Associate Engineer, MSAT (Downstream) will support the successful transfer and execution of new downstream processes into manufacturing, drive process improvement, and provide technical expertise to support process tech transfers.
BiotechnologyHealth CareMedical
Responsibilities
Develop and cultivate positive client and internal Avid group (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships
Capable of contributing to a project from start to finish with supervision in support of the MSAT technical Subject Matter Expert (SME)
Ability to communicate with client on process status and collaborate to resolve issues on the floor
Provide technical expertise to support process tech transfers, troubleshoot process issues, and implement process improvements
Author Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures, User Requirement Specifications, Design Specifications, and Process Validation Protocols
Contribute to proper scale-up assessments to translate executed PD-scale process into manufacturing scale
Assist in proper equipment/facility fit and gap assessments for new processes or process changes to ensure proper execution
Author new product introduction protocols
Monitor process health through process monitoring
Assist in authoring technical risk assessments to identify gaps, incorporate new materials, and/or identify areas of improvement
Provide technical training to Manufacturing Downstream Operators
Assist in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions. Conduct systematic investigations of root causes, problems, or identified risks
Research and identify new material and/or equipment for continuous improvement
Evaluate and assess the impacts of process, material, and equipment changes to product quality attributes
Prepare analysis and reports of proposed changes that are based on sound scientific and engineering principles
Ability to perform statistical analysis of data to form conclusions and recommendations
Performs other duties as assigned
Qualification
Required
Bachelor's degree in scientific or engineering (chemical or biomedical) discipline
Minimum of 1 year of downstream biologic manufacturing or process downstream development
Quality assurance knowledge
Hands-on experience with depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills
Hands-on experience with downstream process equipment including, but not limited to AKTA ready column chromatography skids, large-scale filtration skids, Unicorn software
Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles
Batch production record, technical risk assessment, and/or technical protocol/study generation and review
Preferred
Master's degree in scientific or engineering (chemical or biomedical) discipline
Technical transfer, scale-up, and mass transfer of downstream processes
JMP statistical software
Benefits
Health, dental, and vision insurance
401(k) matching
Paid time off
Company
Avid Bioservices
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.
201-500 employees
H1B Sponsorship
Avid Bioservices has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$285M2024-11-06Private Equity
2024-11-06Acquired
2024-03-06Post Ipo Debt· $160M
Leadership Team
Kenneth Bilenberg
President & Chief Executive Officer
Recent News
2025-11-13
2025-11-10
Company data provided by crunchbase