Senior Specialist, Engineering

Location: Elkhorn

** Job Description*
* The function of Senior Specialist, Engineering at Bio Technology and Solutions (BTS) - Tech Hub will have a focus in Vaccine and Biologicals processes development for Manufacturing. BTS Tech Hub is responsible

for process development of production processes. Within a multidisciplinary environment you will cooperate with your colleagues at BTS, Manufacturing, Engineering, Quality and R&D. Your main field of attention is to provide all round technological support on Vaccine and Biologicals Manufacturing of new (R&D) products.

** Primary Responsibilities*
* + 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.

+ 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.

+ 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.

+ Leads and works independently as a team member on technical investigations, validation and/or process improvement projects.

+ Examines issues from diverse perspectives (safety, compliance, automation, equipment, process and people) in order to best understand and resolve the root cause.

+ Whether or not in collaboration with team members from other departments (e.g. QC, Pharmaceutical Technical Support, R&D, Production or Analytical Technical Services) gives direction to scientifically based decisions within projects aimed at the improvement of products, solving problems or development of new products.

+ Implement development, introduction and/or testing of new technologies Collaborates and interfaces with R&D and Manufacturing and other departments to bring new products to market.

+ Leads large cross-functional teams and demonstrates working knowledge of current USDA regulatory guidelines and advanced technical knowledge.

+ Develops project charters and project plans and align with all sponsors and stakeholders.

+ Key capabilities include standard project management activities: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification tracking and mitigation.

+ Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders and escalates issues to sponsors as needed in advance of deviation from project plans.

+ In concert with Commercialization, Quality, and Regulatory, support inspection readiness. Assures consistent application of standardized work, engineering and process tools

+ Conducts and design experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

+ Creates and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

+ Displays our Company leadership behaviors and demonstrate a high emotional intelligence

+ Effectively collaborates with peers on site and above site as required.

+ Contributes to international projects (Global Projects).

+ Interacts closely with fellow scientists from your own and other departments. If required with external collaboration partners.

+ Actively contributes to the improvement or acceleration of activities within the department, also in the field of Environment Health and Safety.

+ Trains and guides employees and / or trainees

** Education Minimum Requirement*
* + Bachelor degree in Biochemical Engineering, Biotechnology, Chemical Engineering, Biology, Biochemistry, Protein Chemistry, Microbiology +5 years' experience in vaccine/biopharmaceuticals Research and Development, Process Development and/or Biological manufacturing or closely related field (or Master degree + 3 years' experience or PhD in related field).

** Required Experience and Skills*
* + 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

** Preferred Experience and Skills*
* + 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…