Senior Specialist, Engineering

Merck Merck · Pharma · NE

This role focuses on process development and scale-up for vaccine and biologicals manufacturing within a biotechnology and solutions tech hub. It involves leading independent work on cultivation, purification, and formulation processes, transferring technologies to production lines, and conducting technical investigations. The role requires strong project management, problem-solving, and collaboration skills, with a working knowledge of USDA regulatory guidelines.

What you'd actually do

  1. Leads and works independently as a team member on the development and scale up of processes or technologies of microbial, virus and cell cultivations, biomolecules concentration and purification and final formulation of veterinary vaccines and therapeutics.
  2. Leads and works independently as a team member on the transfer of processes or technologies of microbial, virus and cell cultivations, biomolecules concentration and purification and final formulation of veterinary vaccines and therapeutics to the production lines.
  3. Leads and works independently as a team member on the development of processes or technologies and its transfer to the production lines within the timelines set for this purpose, whereby these processes and technologies meet the requirements of the customer with regard to safety, quality, cost-efficiency, practical applicability and consistency.
  4. Leads and works independently as a team member on technical investigations, validation and/or process improvement projects.
  5. Examines issues from diverse perspectives (safety, compliance, automation, equipment, process and people) in order to best understand and resolve the root cause.

Skills

Required

  • Excellent written and verbal communication
  • Excellent project management, documentation and writing
  • Excellent teamwork
  • Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance)
  • Work together in multidisciplinary and international teams
  • Adaptability
  • Data Analysis
  • Interpersonal Relationships
  • Manufacturing Processes
  • Production Process Development
  • Project Management
  • Regulatory Compliance
  • Root Cause Analysis (RCA)

Nice to have

  • 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 and application to process monitoring and control
  • Molecular biology, replicon particles, cell cultivation

What the JD emphasized

  • USDA regulatory guidelines
  • GMP requirements for manufacture and testing of biological products