Senior Operations Engineer - Drug Product
Core
Support commissioning, qualification, start-up, and operational readiness of a new Small Molecule drug product manufacturing facility in Elkton, VA.
Role type
Senior Operations Engineer (Drug Product)
Builds
New small molecule manufacturing facility for patients in the U.S.
Domain
Biopharmaceutical manufacturing (Small Molecule)
Required skills
Chemical Engineering, cGMP Compliance, Manufacturing Processes, Process Optimization, Lean Six Sigma, Cross-Functional Project Management, Operational Quality, Troubleshooting, Technology Transfer
Preferred skills
Greenfield facility start-up, Commissioning/Qualification/Validation, Technology Transfer implementation, Shift coordination, Leadership continuity
Technologies
MPS (Production System), Kaizen, 5S, Standard Work
Responsibilities
Support equipment and process start-up and troubleshooting; Coordinate improvement activities across the Integrated Product Team; Define and improve operating practices and standard work; Embed best practices across shifts and functions; Act as a delegate for the Production Lead.
Seniority
Senior, hands-on IC
