Vaccine Process Engineering Specialist

Socket.dev; Durham (NC); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Durham, NC is seeking a Technology Operations Specialist to lead vaccine process technologies, support drug substance and media development, and drive post-approval enhancements.

The role requires strong technical leadership, cross-functional collaboration, and excellent communication skills. You will participate in technology transfer, author critical technical documents, and assist in regulatory interactions while supporting on-shift coverage and continuous improvement

Qualifications

• Education: Bachelor's or Master's in a life sciences field with relevant experience.
• Experience in vaccine/biologics manufacturing within a cGMP environment.
• Ability to author technical documentation for regulatory filings including risk assessments.

Responsibilities

• Provide technical and team leadership for commercial technology transfer and qualification studies for vaccine processes.
• Lead cross-functional teams to advance projects, ensuring on-time delivery and compliance.
• Author/review technical documents and regulatory filings; support change control activities.
• Support regulatory inspections and respond to questions from multiple agencies (FDA/EMA).
• Mentor and coach junior staff, fostering a collaborative, growth-focused environment.

Skills

cGMP experience

Leadership

Technical writing

Project management

Cross-functional collaboration

Regulatory communication

Mentorship

Problem solving

Education

Bachelor's degree in Chemical Engineering/Biochemical Engineering/Bioengineering or related life science

Master of Science degree

Tools

SAP

MES

DeltaV

Job description

Merck & Co., Inc. in Durham, NC is seeking a Technology Operations Specialist to lead vaccine process technologies, support drug substance and media development, and drive post-approval enhancements.

The role requires strong technical leadership, cross-functional collaboration, and excellent communication skills. You will participate in technology transfer, author critical technical documents, and assist in regulatory interactions while supporting on-shift coverage and continuous improvement