Manufacturing Changeover Manager - Drug Substance
Merck
Manufacturing Changeover Manager for drug substance operations at a small molecule facility in Elkton, Virginia. This role plans and executes turnaround activities between manufacturing campaigns, leads cross-functional teams, and drives operational excellence through standardized processes and continuous improvement.
Responsibilities
- Plan, coordinate, and execute turnaround activities for drug substance operations between campaigns
- Lead mechanical, electrical, operations, and production personnel to ensure safe and efficient changeovers
- Develop and maintain standardized, repeatable turnaround models supporting consistent campaign transitions
- Monitor performance metrics and apply lean tools to reduce downtime and improve cycle time
- Partner with production leads and cross-functional teams to ensure readiness and execution alignment
Requirements
- Bachelor's degree in engineering, operations, manufacturing, or related technical discipline
- Minimum 5 years pharmaceutical, biotechnology, or regulated GMP manufacturing experience
- Experience leading turnaround, changeover, or campaign transition activities
- Strong lean principles knowledge and continuous improvement mindset
- Proven team leadership and cross-functional coordination in manufacturing
- Knowledge of safe, compliant execution in regulated environments
- Strong planning, problem-solving, and decision-making capabilities
Vacancy posted 5 days ago
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