Principal Engineer, MSAT Upstream
About the role
Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet client needs and improve patient outcomes. As the Principal Engineer, Manufacturing Sciences & Technology (MSAT) Upstream, you will act as a subject matter expert, leading client and internal projects with enhanced technical acumen and process knowledge. This role supports manufacturing process teams as a technical resource, aids with complex tasks, and supplements routine operations. You will ensure the robustness of manufacturing processes and equipment by driving continuous improvements and applying best practices across manufacturing operations and MSAT systems. Additionally, you may undertake managerial roles for the Upstream MSAT team as a backup for leadership.
Responsibilities
- Perform all Senior Engineer MSAT responsibilities and essential functions.
- Develop and cultivate positive client and internal partnerships across groups such as PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.
- Oversee projects from start to finish with minimal supervision as the technical Subject Matter Expert (SME).
- Monitor Process Health through continuous process monitoring.
- Drive cost-saving measures regarding raw materials and process improvements.
- Mentor other MSAT engineers and independently lead/manage MSAT teams.
- Create high-performing teams.
- Prepare analysis and reports of proposed changes based on sound scientific and engineering principles.
- Perform statistical analysis of data to form conclusions and recommendations.
- Identify and initiate process and procedural changes to improve performance, robustness, productivity, safety, efficiency, and compliance.
- Research and identify new materials and/or equipment for continuous improvement, evaluating impacts on product quality attributes.
- Author and review Technical Risk Assessments to identify gaps, incorporate new materials, and highlight areas of improvement.
- Provide technical training to Manufacturing Operators and other teams.
- Conduct systematic investigations of root causes, problems, or identified risks.
- Provide technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
- Execute additional short-term and/or long-term projects to improve MSAT systems.
- Perform other duties as assigned.
Requirements
- B.S./M.S. in a scientific or engineering discipline (chemical or biomedical).
- 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 aseptic technique, single-use bioreactors, single-use centrifuges, and DeltaV software.
- Track record of analyzing and resolving complex manufacturing and production issues using sound scientific principles.
- Ability to work independently, lead small matrix and cross-functional teams in a fast-paced environment with changing priorities.
- 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.
- Experience with batch production records, technical risk assessments, and technical protocol/study generation and review.
- Customer service experience via escorting persons in plant (PIP) or prior work experience.
- Strong knowledge of cGMPs or equivalent standards.
- Sound decision-making skills to resolve or escalate deviations and issues on the production floor.
- Clear and professional verbal and written communication skills.
- Proficient time management, multitasking, and project oversight skills.
- Strong leadership and management skills.
Benefits
- Competitive base salary and performance-based bonuses.
- Comprehensive benefits including health, dental, and vision insurance.
- 401(k) matching.
- Paid time off.
- Opportunities for career growth and development.
- Supportive and inclusive work environment.
Pay
The compensation range for this role is $147,200 - $184,000 annually, depending on experience and qualifications.
Schedule
This is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by a supervisor. The employee must be able to work overtime and/or weekends when necessary.
Physical Demands & Work Environment
This role involves a blend of regular activities such as sitting, standing, and walking, with occasional physically engaging tasks like lifting objects up to 25 pounds. The work environment may expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. Reasonable accommodations are available to support individuals with different abilities. Visual acuity, including close, distance, and color vision, is essential for navigating day-to-day demands.