Associate Engineer, MSAT (Downstream)
Company: Avid Bioservices
Location: Tustin
Posted on: April 3, 2026
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Job Description:
Description Looking 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 Associate
Engineer, MSAT (Downstream) ’s primary responsibilities are to
support the successful transfer and execution of new downstream
processes into manufacturing. This requires an understanding of
manufacturing downstream equipment and techniques to set up the
manufacturing downstream operations for success. The Associate
Engineer, MSAT (Downstream) should be capable of contributing to
technical discussions on MSAT projects. The Associate Engineer,
MSAT (Downstream) will drive process improvement to increase
efficiency and decrease risk. 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. Minimum
Qualifications: 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 Qualifications: Master’s degree in
scientific or engineering (chemical or biomedical) discipline.
Technical transfer, scale-up, and mass transfer of downstream
processes. JMP statistical software. Position Type/Expected Hours
of Work: This role is a full-time position operating Monday through
Friday. The employee must also, if instructed, be able to work
overtime, holidays and/or weekends when needed. 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
$65,00-$87,700 annually depending on experience and qualifications.
Additionally, we offer opportunities for career growth and
development as well as a supportive and inclusive work environment.
We understand the importance of attracting and retaining top
talent. The expected base pay range for this position is
($65,800-$87,700) annually plus bonus, and comprehensive benefits.
The base pay range reflects the target range for this position, but
individual pay will be determined by additional factors such as
job-related skills, experience and relevant education or training.
Our benefits include health, dental and vision insurance benefits
to ensure your well-being. 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 20 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.
Keywords: Avid Bioservices, Orange , Associate Engineer, MSAT (Downstream), Science, Research & Development , Tustin, California