Senior Specialist, Operations

Merck KGaA Darmstadt Germany - Durham, NC

Full-time - Entry Level

Onsite - Durham, NC

Chemical Manufacturing

About the position

The Operations Specialist will play a crucial role in the Vaccine Manufacturing Organization, specifically within the Durham team. This position focuses on supporting production activities on the floor, ensuring compliance with safety and quality standards, and driving continuous improvement initiatives. The Operations Specialist will be responsible for batch record review, problem-solving, and providing leadership in the absence of shift managers, all while fostering a positive and inclusive work environment.

Responsibilities

• Provides support for all production activities, resolving critical issues on a daily basis to ensure consistent supply.
• Facilitates real-time root cause analysis to solve routine production and equipment problems.
• Assists shift managers in providing leadership to the production floor.
• Capable of providing primary leadership to the team during extended periods of manager absence such as vacations.
• Works in an inclusive manner, treating all team members with respect and helping to create a positive and continuously improving work environment within the team.
• Possesses basic compliance experience (GMP and Environmental Health & Safety) and participates positively in both internal and external regulatory inspections.
• Executes and manages Operations batch record review within established timelines for release and effectively liaises with Quality to resolve comments in a timely manner.
• Provides technical expertise and oversight on the production floor, including critical processing observation and real-time feedback.
• Facilitates routine meetings and manages metrics to ensure effective communication and commitment fulfillment.
• Drives continuous improvements and corrective actions within the team.

Requirements

• Bachelor's Degree in Engineering (Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, Industrial Engineering) or Science Fields (Chemistry, Biology, Microbiology) strongly preferred.
• Minimum four years relevant manufacturing, technical, or mechanical support role in a high-volume lean operation.
• Working knowledge of cGMP and regulatory requirements as they apply to the vaccine and/or pharmaceutical industry.
• Highly motivated with strategic and effective interpersonal, problem-solving, and technical skills.
• Strong verbal and written communication skills.
• Ability to work in a team environment, collaborating effectively with other team members and external stakeholders.

Nice-to-haves

• cGMP in an aseptic manufacturing environment
• Inventory management and maintenance planning software experience
• Basic problem-solving techniques such as root cause analysis and/or Lean Six Sigma
• Project management skills and experience implementing small-sized assignments
• Technical writing and document review experience (deviations, change requests, standard operating procedures, batch records, protocols)

Benefits

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