API Operations Lead for Start-Up & Process Excellence

MSD Malaysia; Virginia (MN); Hybrid; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical benefits

401(k) retirement plan

Job summary

Merck & Co., Inc. in the United States is hiring an API Operations Specialist to support commissioning, qualification, start-up, and readiness of a new Small Molecule facility in Elkton, Virginia.

The role collaborates with Operations, Engineering, Quality, and Technical Operations to ensure safe, compliant production and continuous improvement. Key responsibilities include coordinating technology transfer and implementing best practices using Lean methods, with a focus on safety and operational

Qualifications

• Bachelor’s degree in a technical discipline; 5+ years API small molecule manufacturing experience.
• Experience in cross-functional manufacturing environments.
• Experience with GMP, quality, and regulatory compliance.
• Strong problem-solving, communication, collaboration, and organizational skills.

Responsibilities

• Support commissioning, qualification, start-up and readiness of the Elkton, VA API facility.
• Coordinate with Operations, Engineering, Quality and other stakeholders to ensure safe, compliant start-up.
• Define and improve operating practices, standard work, procedures and routines.
• Apply lean tools (Kaizen, 5S, Standard Work) to drive improvements across shifts and teams.
• Promote safety, quality, compliance, and continuous improvement.

Skills

cGMP Compliance

Data Analysis

Lean Management

Operational Excellence

Production Planning

Education

Bachelor's degree preferred in a technical discipline

Tools

MPS tools

Job description

Merck & Co., Inc. in the United States is hiring an API Operations Specialist to support commissioning, qualification, start-up, and readiness of a new Small Molecule facility in Elkton, Virginia.

The role collaborates with Operations, Engineering, Quality, and Technical Operations to ensure safe, compliant production and continuous improvement. Key responsibilities include coordinating technology transfer and implementing best practices using Lean methods, with a focus on safety and operational