Senior API Operations Specialist – Small Molecule Start-Up

Merck & Co.; Elkton (VA); On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Sick days and compassionate days

Job summary

Merck & Co. in Elkton, VA, seeks an API Operations Specialist to support commissioning, qualification, start-up, and readiness of a new small molecule facility.

You will work with Operations, Engineering, Quality, Technical Operations and Supply Chain to ensure safe, compliant start-up and early production. This role emphasizes process improvements using lean tools and technology transfer, with a strong focus on safety and operational excellence.

Qualifications

• Bachelor's degree preferred in a technical discipline; engineering degree not required.
• Minimum 5 years API Small Molecule manufacturing experience.
• Experience with GMP, quality, and compliance in pharmaceutical manufacturing.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness for the new API Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain to ensure safe, compliant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Help define, implement, and improve operating practices, standard work, procedures, and routines for reliability and compliance.
• Coordinate and prioritize improvement activities within the IPT aligned with business objectives.
• Utilize Production System tools and lean principles (Kaizen, 5S, Visual Management, Standard Work) to identify improvements.
• Embed best practices across shifts and functions for consistency and efficiency.
• Support a culture of safety, quality, compliance, accountability, and continuous improvement.
• Act as delegate for the Production Lead when needed to sustain leadership continuity.
• Contribute to an inclusive, collaborative, and performance-driven environment.

Skills

Adaptability

Analytical Problem Solving

GMP Compliance

Lean Management

Process Optimization

Production Planning

Education

Bachelor's degree in Chemical/Pharma Eng or Chemistry

Job description

Merck & Co. in Elkton, VA, seeks an API Operations Specialist to support commissioning, qualification, start-up, and readiness of a new small molecule facility.

You will work with Operations, Engineering, Quality, Technical Operations and Supply Chain to ensure safe, compliant start-up and early production. This role emphasizes process improvements using lean tools and technology transfer, with a strong focus on safety and operational excellence.