Sr. Specialist, Engineering

Lead and Support

• Optimization, Troubleshooting, Investigations, Validation, and Process Improvement
• Technical Support for Complex Commercial Vaccine Manufacturing
• Technology Transfer, New Process/Product Introductions, Comparability Activities, and Manufacturing Improvements
• Resolve Manufacturing Challenges with Urgency
• Evaluate Technical Issues from Multiple Perspectives
• Develop Project Charters, Plans, Timelines, Deliverables, Risk Mitigation Plans, Tracking Tools, and Stakeholder Communications
• Coordinate Team Activities, Lead or Participate in Core Team Meetings, Communicate Status and Risks, and Escalate Issues or Opportunities as Needed
• Author and Execute Experimental Protocols, Reports, and Technical/Manufacturing Documents

Education and Experience

• Minimum Requirement: Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, or related field with at least 5 years of experience in vaccine and/or biopharmaceutical Development, Process/Product Development, and/or Biological manufacturing or closely related field.
• (Or Master of Science degree and at least 3 years of experience.)
• Required Experience and Skills:
• Direct experience supporting complex commercial vaccine processes involving viral/vector-based production, cell culture, downstream processing, and sterile fill-finish operations, with additional exposure to other Animal Health vaccine or biological manufacturing platforms.
• Excellent written and oral communication, documentation, and project management skills.
• Strong collaboration skills with experience working across commercial manufacturing teams and multidisciplinary stakeholders, including Operations, Engineering, Quality, Regulatory, Safety, Supply Chain, R&D, and global or site-based partners.
• Strong analytical, problem-solving, and decision-making skills, with a hands-on approach that incorporates safety, quality, compliance, process, equipment, automation, materials, and people considerations.
• Experience supporting complex commercial vaccine manufacturing or technical operations involving viral/vector-based or cell culture-based antigen production, downstream processing, sterile biopharmaceutical operations, and broader familiarity with other vaccine or biological manufacturing processes.
• Experience with process characterization, scale-up/scale-down, process robustness, technical troubleshooting, investigations, protocol execution, and validation support.
• Working knowledge of USDA regulatory guidelines, current GMP expectations, aseptic processing principles, and manufacturing/testing expectations for vaccine or biopharmaceutical products.
• Experience authoring and executing technical protocols and documents, including reports, investigation summaries, change control documentation, comparability assessments, and validation-related documentation.
• High degree of ownership, scientific rigor, urgency, and continuous improvement mindset in support of commercial manufacturing and supply continuity.

Preferred Experience and Skills

• Understanding of statistics and application to process monitoring, control, investigations, and manufacturing data analysis.
• Experience applying standardized work, engineering controls, process analytical technology, or protocol-driven studies to improve process robustness and manufacturing performance.
• Experience introducing, testing, or supporting new technologies, process changes, or improvement initiatives in manufacturing or technical support environments.
• Experience supporting global, multi-site, technology transfer, comparability, or launch-readiness projects.

Schedule

• Able to work first shift, Monday through Friday as base schedule.
• Off-shift coverage may be required based on manufacturing and transfer activities.