Senior API Ops Engineer — Small Molecule Plant

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

Job summary

HireLifeScience in Elkton, Virginia seeks a Senior Operations Engineer - API to lead commissioning and start-up of a new small-molecule facility. You will partner with Operations, Engineering, Quality and Supply Chain to ensure safe, compliant, and efficient operations from project execution through initial manufacturing.

The role emphasizes continuous improvement using Lean tools (Kaizen, 5S, Standard Work), and requires a chemical engineering or related degree with 5+ years API experience.

Qualifications

• Bachelor's degree in a related technical discipline required.
• Minimum 5 years API Small Molecule manufacturing experience including operations or technical operations.
• Working knowledge of GMP, quality, and compliance in pharmaceutical manufacturing.
• Strong problem-solving, communication, collaboration, and organizational skills.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness for the Elkton, VA API facility.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain and other stakeholders for safe, compliant plant start-up.
• Provide technical and operational support during equipment 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.
• Coordinate and prioritize improvement activities within the IPT to align with business objectives.

Skills

cGMP Compliance

Chemical Engineering

Cross-Functional PM

Lean Six Sigma

Operations Engineering

Education

Bachelor's degree

Job description

HireLifeScience in Elkton, Virginia seeks a Senior Operations Engineer - API to lead commissioning and start-up of a new small-molecule facility. You will partner with Operations, Engineering, Quality and Supply Chain to ensure safe, compliant, and efficient operations from project execution through initial manufacturing.

The role emphasizes continuous improvement using Lean tools (Kaizen, 5S, Standard Work), and requires a chemical engineering or related degree with 5+ years API experience.