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, scale-up, and mass transfer of processes.
• Batch production record, technical risk assessment, and technical protocol/study generation and review.
• Customer service skillset via escorting of person in plant (PIP) or through prior work experience.
• Strong knowledge of cGMPs or equivalent standards.
• Sound decision-making skillset to resolve or escalate deviations and/or issues on the production floor.
• Communicate clearly and professionally both verbally and in writing.
• Proficient time management/multi-tasking and project oversite skills.
• Track record of strong leadership and management skillset.

Position Type/Expected Hours of Work: 

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

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 $147,200 - $184,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. 

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 25 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.