Senior Specialist, Technical Operations

Merck KGaA Darmstadt Germany - Durham, NC

Full-time - Senior

Onsite - Durham, NC

Chemical Manufacturing

About the position

The Senior Engineering Specialist will join the Technical Support Operations department within the Manufacturing Division, focusing on process-related problems, projects, and initiatives at the Durham, NC manufacturing facility. This role requires strong leadership, technical writing, and problem-solving skills, with responsibilities including leading critical project initiatives, supporting the manufacturing process, and conducting scientific investigations to determine root causes and develop corrective actions. The position emphasizes a commitment to team culture and continuous learning, with occasional off-shift or weekend coverage required.

Responsibilities

• Lead initiatives supporting the End to End manufacturing process
• Act as Technical Operations Subject Matter Expert (SME)
• Lead and support production and quality projects and process system improvements
• Facilitate real-time formal problem-solving techniques, such as root cause analysis and/or Lean Six Sigma tools
• Support investigations of process deviation events
• Provide technical expertise and oversight on the production floor, understanding full process requirements (safety, compliance, equipment, regulatory) to resolve production issues.

Requirements

• Bachelor of Science (B.S.) degree in Engineering or Science Fields with relevant experience
• Minimum six (6) years of experience in a pharmaceutical Good Manufacturing Practices (GMP) related environment
• Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements in the vaccine/pharmaceutical industry
• Experience with formal problem-solving techniques and hands-on problem-solving approaches
• Experience in project management
• Technical writing experience, including investigations, change requests, standard operating procedures, batch records, protocols
• Ability to work independently and within multi-functional teams in a fast-paced environment.

Nice-to-haves

• Experience with presenting to an internal/regulatory auditor
• Skills in design of experiments (DOE)
• Experience leading and/or facilitating a team for problem-solving/investigative purposes
• Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis
• Sterile manufacturing experience
• Six Sigma certification.

Benefits

• Hybrid work model with three days on-site and two days remote
• Equal Opportunity Employer
• Commitment to diversity and inclusion
• Employee support for accommodations during the hiring process.