Associate Engineer, MSAT (Downstream)

Avid Bioservices-posted about 2 months ago

Full-time • Entry Level

Tustin, CA

251-500 employees

Chemical Manufacturing

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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.

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.

Master's degree in scientific or engineering (chemical or biomedical) discipline.
Technical transfer, scale-up, and mass transfer of downstream processes.
JMP statistical software.

health, dental, and vision insurance
401(k) matching
paid time off
opportunities for career growth and development
supportive and inclusive work environment

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