Specialist, Engineering Projects

Job Description

The West Point ROTA E2E organization is seeking a highly motivated individual for the role of Specialist, Engineering 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

• Support, execute, and/or lead continuous improvement projects aimed at increasing compliance, simplifying and standardizing processes, and improving operational efficiency. May work independently, as part of a team, or as a project lead.
• Complete and/or lead projects designed to enhance process performance. This includes investigating Corrective and Preventive Actions (CAPAs), initiatives to improve Right-First-Time performance, reduce deviations, and execute value-capture projects focused on improving yield and efficiency, reducing costs, or shortening processing cycle times.
• Manage project timelines to ensure compliance requirements and customer deadlines are met. Escalate potential delays and develop remediation plans as needed.
• Collaborate effectively with Coaches, Operators, Mechanics, support teams, Quality, Planning, project teams, and external equipment and component vendors.
• Examine complex issues from multiple perspectives, including safety, compliance, automation, equipment, process, and personnel considerations, to identify and effectively resolve root causes.
• Provide advanced technical support to manufacturing operations for complex process- and equipment-related issues.
• Design, conduct, review, and approve experimental protocols as needed, utilizing Technical Operations laboratory facilities and/or full-scale production equipment.
• Author, update, and review technical and manufacturing documentation required for engineering studies and change control activities.
• Support regulatory inspection activities.
• Provide on-the-floor support for complex operational and technical issues involving processes and equipment.
• Support team objectives related to safety, environmental standards, and regulatory compliance.

Education Minimum Requirement:

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

Required Experience and Skills:

• Minimum of two (2) years of post-bachelor’s degree experience in a GMP-regulated functional area or in support of a GMP-regulated function, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
• Experience supporting change control activities and/or project execution.
• Strong communication, leadership, and teamwork skills.
• Demonstrated ability to manage projects and assignments effectively while meeting established schedules and deadlines.

Preferred Experience and Skills:

• Experience serving as a Change Control author and/or reviewer.
• Experience working in biologics, vaccine, bulk sterile manufacturing, or other GMP-regulated manufacturing facilities.
• Project management experience.

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Bioprocessing, cGMP Compliance, Change Control Processes, Change Controls, Computerized Maintenance Management Systems (CMMS), Continuous Improvement Techniques, Customer Needs Identification, Data Analysis, Detail-Oriented, Engineering Document Management, Engineering Principle, Maintenance Supervision, Manufacturing, Mechanical Systems, Process Control, Process Simplification, Process Standardization, Production Support, Project Management, Project Time Management, Regulatory Compliance, Regulatory Inspections {+ 7 more}

Preferred Skills:

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