Engineer, MSAT Upstream

Avid Bioservices•Tustin, CA

21h•Onsite

About The Position

As an Engineer, MSAT Upstream at Avid Bio, you will be the main point of contact for clients and internal departments, providing technical support and ensuring successful transfer and execution of new upstream processes in manufacturing. You will work closely with our clients to collaborate on upstream process status and troubleshoot issues on the floor. You will also play a critical role in driving process improvement to increase efficiency and decrease risk.

Requirements

Bachelor’s degree in a scientific or engineering discipline (chemical, mechanical, or biomedical).
2 + years of biologic upstream manufacturing experience.
Strong understanding of cGMPs or equivalent standards and be able to make sound decisions to resolve or escalate deviations and/or issues on the production floor.
A team player who can oversee a project from start to finish with little to no supervision.
Track record of strong leadership.
Hands-on experience with cell culture process and aseptic techniques.

Nice To Haves

Masters’ degree in a scientific or engineering discipline (chemical, mechanical, or biomedical).
Hands-on experience with Upstream process equipment (is a plus) including, but not limited to: Large scale single use bioreactors (100L and up) Wave technology Harvest technology (3M, Millistak, and/or centrifuge) DeltaV software (preferred)

Responsibilities

Develop and cultivate positive client and internal Avid group partnerships.
Communicate with clients on process status and collaborate to resolve issues on the floor.
Provide technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
Author Manufacturing Batch Production Records, technical reports, and Process Validation Protocols.
Perform proper scale-up assessments to translate executed PD-scale process into Manufacturing scale and perform proper equipment and facility fit assessment for new processes or process changes to ensure proper execution.
Monitor process health through process monitoring and author technical risk assessments to identify gaps, incorporate new materials, and/or identify areas of improvement.
Provide technical training to Upstream Manufacturing Operators and assist in CAPA investigations and recommend dispositions.
Conduct systematic investigations of root causes or problems or identified risks and evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.
Other tasks as assigned.