Senior Specialist, Engineering

Job Description

Senior Specialist, Engineering – Bio Technology and Solutions (BTS) – Tech Hub, focusing on Vaccine and Biologicals processes development for manufacturing. Responsible for process development and support across BTS, Manufacturing, Engineering, Quality and R&D teams. Provide all‑round technological support for production of new (R&D) products.

• Lead and work independently as a team member on the development and scale‑up of processes or technologies of microbial, virus and cell cultivations, biomolecule concentration, purification and final formulation of veterinary vaccines and therapeutics.
• Transfer processes or technologies of microbial, virus and cell cultivations, biomolecule concentration, purification and final formulation of veterinary vaccines and therapeutics to the production lines.
• Develop processes or technologies and transfer them to the production lines within timelines, ensuring safety, quality, cost‑efficiency, practicality and consistency.
• Conduct technical investigations, validation and process improvement projects.
• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process and people) to understand and resolve root causes.
• Collaborate with team members from QC, Pharmaceutical Technical Support, R&D, Production or Analytical Technical Services to provide direction to scientifically based decisions.
• Implement development, introduction and testing of new technologies; collaborate with R&D and Manufacturing to bring new products to market.
• Lead large cross‑functional teams and demonstrate knowledge of USDA regulatory guidelines and advanced technical knowledge.
• Develop project charters and plans; align with sponsors and stakeholders.
• Define timelines, deliverables, roles and responsibilities, risk identification, tracking and mitigation.
• Coordinate and track team activities; communicate risks and status to stakeholders; raise issues to sponsors as needed.
• Support inspection readiness with Commercialization, Quality and Regulatory; assure application of standardized work and engineering tools.
• Conduct and design experimental protocols using Technical Operations lab facilities and/or production equipment.
• Create and update technical and manufacturing documents for investigations, process design, engineering studies, demonstrations, change control and validation.
• Demonstrate leadership behaviors and high emotional intelligence.
• Collaborate effectively with on‑site and off‑site peers.
• Contribute to international projects.
• Interact with fellow scientists and external collaboration partners as required.
• Improve or accelerate department activities, including Environment Health and Safety.
• Train and guide employees and/or trainees.

• Bachelor’s degree in Biochemical Engineering, Biotechnology, Chemical Engineering, Biology, Biochemistry, Protein Chemistry, Microbiology plus 5 years’ experience in vaccine/biopharmaceutical R&D, Process Development or Biological manufacturing, or a Master’s degree with 3 years’ experience, or a PhD in a related field.

• Excellent written and verbal communication.
• Excellent project management, documentation and writing.
• Excellent teamwork.
• Strong problem‑solving skills and a hands‑on approach inclusive of diverse perspectives (e.g., safety, compliance).
• Experience working in multidisciplinary and international teams.

• Experience in bioprocess scale‑up and vaccine manufacturing.
• Working knowledge of USDA regulations.
• Knowledge of GMP requirements for manufacture and testing of biological products.
• Understanding of statistics applied to process monitoring and control.
• Knowledge of molecular biology, replicon particles, cell cultivation.

• Adaptability.
• Data analysis.
• Interpersonal relationships.
• Manufacturing processes.
• Production process development.
• Project management.
• Regulatory compliance.
• Root cause analysis (RCA).

As an Equal Employment Opportunity Employer, we provide opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex,…