Specialist, Engineering

MSD • Millsboro, DE

2d • $87,300 - $137,400 • Onsite

About The Position

The function of a Specialist at Tech Hub is to provide technical support to Vaccine and Biologicals process development for Manufacturing within a multidisciplinary environment. You will cooperate with your colleagues at Bioprocess Technology Solutions, Manufacturing, Engineering, Quality and R&D. Your main field of attention is to provide all-around technological support on Vaccine and Biologicals Manufacturing of new (R&D) products.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Requirements

• Bachelor’s degree in Biochemical Engineering, Biotechnology, Chemical Engineering, Biology, Biochemistry, Protein Chemistry, Microbiology with 2 years’ experience in vaccine/biopharmaceuticals Research and Development, Process Development and/or Biological manufacturing or closely related field (or Master's degree with 1 years’ experience or PhD in related field).
• Excellent written and oral communication skills.
• Excellent project management, documentation and writing skills.
• Excellent teamwork skills.
• Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance).
• Can work together in multidisciplinary and international teams.
• Adaptability
• Animal Vaccination
• Biopharmaceuticals
• Change Control Management
• Chemical Engineering
• Chemical Technology
• Data Analysis
• Equipment Troubleshooting
• Global Manufacturing
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Identifying Risks
• Inspection Readiness
• Lean Manufacturing
• Multidisciplinary Collaboration
• New Product Development
• Personal Initiative
• Process Optimization
• Professional Integrity
• Project Management
• Protein Chemistry
• Root Cause Analysis (RCA)
• Teamwork
• Technical Writing

Nice To Haves

• 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.

Responsibilities

• Works 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.
• Works 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.
• Works 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.
• Works 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.
• Gives direction to scientifically based decisions within projects aimed at the improvement of products, solving problems or development of new products, whether or not in collaboration with team members from other departments (e.g. QC, Pharmaceutical Technical Support, R&D, Production or Analytical Technical Services).
• Performs development, introduction and/or testing of new technologies if necessary. Collaborates and interfaces with R&D and Manufacturing and other departments to bring new products to market.
• Works within 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 for new product introductions and transfers.
• Assures consistent application of standardized work, engineering and process tools. Conducts and designs 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 company's 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.
• Performs off-shift work (only as needed).

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level