Engineer, MSAT Downstream

Avid Bioservices

6d•Onsite

About The Position

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. The Engineer, MSAT Downstream’s primary responsibilities are to ensure successful transfer and execution of new processes in Manufacturing and be the main point of contact for clients and internal departments for technical support. This requires knowledge in scaling processes, understanding of manufacturing equipment limitations, and setting up Manufacturing Operations for success. The MSAT Engineer also drives process improvement to increase efficiency and decrease risk.

Requirements

B.S./M.S. in scientific or engineering (chemical, mechanical or biomedical) discipline.
2-3 years of biologic manufacturing process development.
Demonstrated track record of analyzing and resolving complex manufacturing and production issues using sound scientific principles.
Experience with tech transfer, scale-up, BPR review, person in plant, process sciences.
Strong knowledge of cGMPs or equivalent standards.
Ability to make sound decisions to resolve or escalate deviations and/or issues on the production floor.
Ability to communicate clearly and professionally both in writing and verbally.

Nice To Haves

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.

Responsibilities

Communicate with clients on process status and collaborate to resolve issues on the floor.
Provides technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
Authors Manufacturing Batch Production Records, Technical Reports, and Process Validation Protocols
Perform proper scale-up assessments to translate executed PD-scale process into Manufacturing scale.
Perform proper equipment and facility fit assessment for new processes or process changes to ensure proper execution.
Monitor Process Health through process monitoring.
Author Risk Assessments to identify gaps and identify areas of improvement
Provide technical training to Manufacturing Operators
Assist in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions.
Conduct systematic investigations of root causes or problems or identified risks.
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.
Perform other duties as assigned.