Principal Engineer, MSAT Upstream

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 Principal Engineer, Manufacturing Sciences & Technology (MSAT) Upstream will act as a subject matter expert and will lead client and internal projects with enhanced technical acumen and process knowledge. This role provides the manufacturing process teams support as a technical resource and aid with complex tasks and supplement routine operations. The Principal Engineer, MSAT will ensure the robustness of manufacturing processes and/or equipment by driving continuous improvements and applying best practices across manufacturing operations and/or MSAT systems.  Furthermore, the Upstream Principal Engineer may undertake managerial roles for the Upstream MSAT team as a backup for Upstream MSAT leadership.

Key Responsibilities:

• Able to perform all Sr. Engineer MSAT responsibilities/essential functions.
• Develops and cultivates positive client and internal Avid group (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships.
• Capable of overseeing a project from start to finish with little to no supervision as the technical Subject Matter Expert (SME).
• Monitors Process Health through continuous process monitoring.
• Drives cost-saving measures regarding raw materials and process improvements.
• Strong leadership skillset to mentor other MSAT engineers. Able to independently lead/manage other MSAT engineers. Creates high performing teams.
• Prepares analysis and reports of proposed changes that are based on sound scientific and engineering principles. Performs statistical analysis of data to form conclusions and recommendations.
• Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency, and compliance.
• Researches and identifies new material and/or equipment for continuous improvement and evaluates and assesses the impacts of process, material, and equipment changes to product quality attributes.
• Authors and reviews Technical Risk Assessments to identify gaps, incorporate new materials, and/or identify areas of improvement.
• Provides technical training to Manufacturing Operators and other teams.
• Conducts systematic investigations of root causes, problems, or identified risks. Provides technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
• Will need to be a self-starter, strongly motivated and able to work independently without supervision.
• Execute additional short-term and/or long-term projects and assignments to improve MSAT systems.
• Perform other duties as assigned.

Minimum Qualifications:

• B.S/M.S. in scientific or engineering (chemical or biomedical) discipline.
• Minimum of 4 years of MSAT experience.
• Minimum of 8 years of manufacturing experience.
• Quality assurance knowledge/experience.
• Biologics experience is required.
• Strong scientific and technical experience within relevant manufacturing process technologies and unit operations. Experience with commercial cGMP manufacturing.
• Expertise in processes such as cell culture, single-use bioreactor activities, centrifugation, and depth filtration.
• Hands-on experience with process equipment including, but not limited to, aseptic technique, single-use bioreactors, single-use centrifuges, and deltaV software.
• Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.
• The ability to work independently and effectively and lead small matrix and cross-functional teams in a fast- paced environment with changing priorities and a high level of urgency.
• Experience with drafting and reviewing regulatory submissions, responding to agency information requests and fronting agency audits.
• Technical transfer, sca