Senior Specialist, Engineering | Technical Operations | Vaccine Manufacturing

Merck & Co. - West Point, PA

Full-time - Mid Level

Onsite - West Point, PA

1,001-5,000 employees

Chemical Manufacturing

About the position

The Sr. Specialist, Engineering will play a crucial role in supporting the start-up of a new vaccine filling and lyophilization facility at the West Point site. This position involves leading process initiatives, supporting process transfers and qualifications, and ensuring compliance with regulatory standards while fostering a culture of continuous improvement and teamwork within a cross-functional environment.

Responsibilities

• Lead and/or work as a technical leader on process initiatives associated with product transfers and/or commercial production.
• Set and drive strategic initiatives associated with process transfers.
• Support the facilitation of tactical initiatives related to process design, engineering studies, process simulations, and change control.
• Author and update technical and manufacturing documents necessary for process design and qualification.
• Develop and execute process change controls, including risk and impact assessments.
• Support process improvement projects and complex manufacturing investigations.
• Provide technical support to manufacturing for complex problems and issues.
• Support digital and data integrity initiatives for the project.
• Develop and assure consistent application of standardized work and engineering tools.
• Examine issues from diverse perspectives to understand and resolve root causes.
• Support regulatory submission preparation and inspections for the facility.

Requirements

• Bachelor's degree in Engineering, Science, or a related field.
• Minimum 5 years of experience in GMP manufacturing or technical support of GMP operations (or M.S. degree with less than 4 years experience).
• Demonstrated strong performance record and excellent project management skills.
• Strong communication and collaboration skills with the ability to drive accountability.
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

Nice-to-haves

• Experience leading and managing departmental or cross-functional teams.
• Experience in technology transfer and/or facility start-up projects.
• Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies.
• Regulatory inspection presentation experience with external regulatory authority representatives.

Benefits

• Health insurance
• Dental insurance
• 401k
• Paid holidays
• Flexible scheduling
• Professional development opportunities