Sr. Spclst, Engineering - Projects

Job Description

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.

The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees.  This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future.

The West Point ROTA E2E organization is seeking a highly motivated individual for the role of Senior Specialist, Engineering (Projects) within the ROTA E2E Strategic Projects Technical Operations team. This role will provide end-to-end technical support for commercial vaccine products within the ROTA Organization. The incumbent will have the opportunity to contribute to the performance and results of multiple Vaccine manufacturing and Packaging areas by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions.

Position Responsibilities

• The Senior Specialist, ROTA E2E Projects Technical Operations, is responsible for leading and executing technical projects through all phases, including project planning, management, and execution.

• Support, execute, and/or lead continuous improvement projects aimed at increasing compliance, simplifying, and standardizing processes, and gaining efficiencies. Works as an individual contributor, as part of a team, or as a project lead.

• Complete and/or lead projects to enhance the performance of our processes. This includes investigating Corrective/Preventive Actions (CAPAs), initiatives aimed at improving Right-First-Time performance, reducing deviations, and value capture projects focusing on improving yield and efficiency, reducing costs, or lowering processing cycle times.

• Manage project timelines to ensure compliance and customer deadlines are met. Escalates potential delays and develops remediation plans as needed.

• Collaborate effectively with Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.

• Examine complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and effectively resolve the root causes.

• Provide advanced technical support to manufacturing for complex problems and issues related to both processes and equipment.

• Design, conduct, review, and approve experimental protocols as necessary, utilizing the Technical Operations lab facilities and/or full-scale production equipment.

• Author, update, and review technical and manufacturing documents required for engineering studies and change controls.

• Support regulatory inspection activities.

• Provide on-the-floor support for complex operational and technical (process/equipment) issues.

• Supports team objectives related to safety, environmental standards, and compliance.

Education Minimum Requirement:

• Bachelor's degree in engineering or other equivalent technical field

Required Experience and Skills:

• Minimum five (5) years post-bachelor degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance (or M.S degree with 3 years of experience)

• Strong communication, collaboration skills, leadership, and ability to drive accountability.

• Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.

• Change control and/or project support role.

• Demonstrated strong performance record and excellent project management skills.

• Experience leading and managing departmental or cross-functional teams.

Preferred Experience and Skills:

• Proficiency with pharmaceutical industry technical business processes such as: Change control author/reviewer, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.

• Experience in technology transfer and/or start-up projects.

• Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.

• Regulatory inspection presentation experience with external regulatory authority representatives

Current Employees apply