Sr. Spclst, Engineering - Projects

Merck & Co. • West Point, PA

425d • Onsite

About The Position

The Senior Specialist, Engineering (Projects) role within the ROTA E2E Strategic Projects Technical Operations team at our West Point, PA campus is focused on providing end-to-end technical support for commercial vaccine products. This position is integral to enhancing the performance and results of multiple vaccine manufacturing and packaging areas, ensuring compliance and efficiency in operations.

Requirements

• Bachelor's degree in engineering or equivalent technical field.
• Minimum five years of experience in a GMP functional area or support of a GMP functional area.
• Strong communication, collaboration, and leadership skills.
• Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.
• Demonstrated strong performance record and excellent project management skills.

Nice To Haves

• Proficiency with pharmaceutical industry technical business processes such as change control and deviation management.
• Experience in technology transfer and/or start-up projects.
• Regulatory inspection presentation experience with external regulatory authority representatives.

Responsibilities

• Lead and execute technical projects through all phases, including project planning, management, and execution.
• Support, execute, and/or lead continuous improvement projects aimed at increasing compliance and efficiency.
• Investigate Corrective/Preventive Actions (CAPAs) and initiatives to improve Right-First-Time performance.
• Manage project timelines to ensure compliance and customer deadlines are met, escalating potential delays as needed.
• Collaborate with various teams including Coaches, Operators/Mechanics, Quality, and external vendors to resolve complex issues.
• Provide advanced technical support for complex problems related to processes and equipment.
• Design, conduct, review, and approve experimental protocols as necessary.
• Author, update, and review technical and manufacturing documents required for engineering studies and change controls.
• Support regulatory inspection activities and provide on-the-floor support for operational issues.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees