Senior Operations Engineer - Drug Product

About the role

The Senior Operations Engineer - Drug Product supports the DP and SDI Integrated Product Team (IPT) in the commissioning, qualification, start‑up, and operational readiness of the new Small Molecule manufacturing facility in Elkton, Virginia. This role partners with cross‑functional teams to help ensure safe, compliant, and efficient operations during project execution and through ongoing manufacturing.

Key responsibilities

• Support commissioning, qualification, start‑up, and operational readiness activities for the new DP Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to support safe, compliant, and effective plant start‑up.
• Provide technical and operational support during equipment and process start‑up, troubleshooting, and optimization activities.
• 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 that support reliable and compliant operations.
• Coordinate and prioritize improvement activities and key areas of focus within the IPT in alignment with business objectives and operational performance goals.
• Use Production System tools and lean principles (Kaizen, 5S, visual management, Standard Work) to identify and support improvement opportunities.
• Act as a delegate for the Production Lead when needed, supporting continuity of leadership and cross‑functional coordination.

Required profile

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline.
• Minimum 5 years of experience in Drug Product/SDI manufacturing, including operations and technical operations.
• Experience working in a cross‑functional manufacturing, technical, or operational setting.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem‑solving, communication, collaboration, and organizational skills.
• Ability to prioritize work in a dynamic, fast‑paced environment.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.

Required skills

• cGMP Compliance
• Chemical Engineering
• Data Analysis
• Lean Six Sigma Continuous Improvement
• Manufacturing Processes
• Manufacturing Systems
• Manufacturing Technologies
• Operational Quality
• Operations Engineering
• Pharmaceutical Process Development
• Pharmaceutical Process Engineering
• Process Improvements
• Process Optimization