Technical & Manufacturing Specialist

3 days ago


Waterville, Maine, United States Elanco Full time
About the Role

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. As a global leader in animal health, we are committed to advancing the health of animals, people, the planet, and our enterprise.

Key Responsibilities
  • Process Improvement: Identify and prioritize strategies to reduce/mitigate negative impact on key success factors.
  • Troubleshooting and Root Cause Analysis: Perform troubleshooting and Root Cause Analysis in Critical Process Deviations to prevent its recurrence, independently or in collaboration with multifunctional teams.
  • Liaison and Support: Provide liaison and support to local and network Quality Control (QC) and Analytical Science and Technology (AS&T) for assay performance troubleshooting and improvement.
  • Manufacturability Review: Supports Elanco Manufacturability Review process for veterinary vaccines.
  • Process Development: Develop short- and long-term strategies to improve existing manufacturing processes and collaborate with other TS/MS-Scientists in corrections needed in the processes to maintain them in a capable state.
  • Experimentation and Analysis: Independently and collaboratively lead and execute experiments that identify the real root cause.
  • Standard Operating Procedures: Suggest changes/improvements to update or improve existing Standard Operating Procedures (SOPs) and manufacturing batch records as it is needed.
  • Quality Management System: Perform and suggest changes to the processes maintaining the compliance with the current Quality Management System (Change Control Process) and Regulatory Regulations.
  • Process Capability Analysis: Identify critical parameters in the production processes, analyze trends and perform statistical analysis to support changes and propose solutions.
  • Regulatory Compliance: Collaborate with Regulatory Affairs in the justification of changes in Special Outlines and Outlines of Production as needed.
  • Training and Development: Train operators, laboratory technicians, supervisors, etc., when new process, equipment or methodologies are implemented in the required functional area (s).
Requirements
  • Education: Bachelor's degree in Engineering, Chemistry, Biology, Biochemistry, Veterinary Sciences, or other related field.
  • Experience: 3+ years experience in the Biotech / Pharmaceutical industry.
  • Skills: Detailed understanding of biopharmaceutical production processes and technologies, working knowledge of cGMP standards, and experience working in a regulated environment.
  • Personal Qualities: Proven analytical thinking and problem-solving skills, demonstrated success operating in cross-functional teams, self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.


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