Lead Process Engineer-Equipment

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Overview

The Lead Process Equipment Engineer is accountable for driving optimal equipment design, reliability practices, and continuous improvement initiatives to exceed customer expectations. Serves as the SME on process equipment with deep knowledge of equipment operation across polymer, sterile, and oral solid dosage (OSD) pharmaceutical processes. This role leads and contributes to continuous improvement projects aligned with commercial and clinical production needs. Responsibilities include troubleshooting automated equipment, implementing improvements, and ensuring regulatory documentation and operational protocols comply with requirements. The position collaborates cross-functionally with Engineering, Reliability, Manufacturing and Quality to strengthen equipment reliability and proactively mitigate supply chain risk.

Responsibilities

• Serve as Equipment Owner for key manufacturing assets, driving strategic improvements, reliability initiatives, and capacity readiness to meet customer demand.
• Lead design, procurement, installation, startup, and commissioning of new process equipment.
• Troubleshoot automated equipment for pharmaceutical formulation and packaging.
• Partner with manufacturing and maintenance teams on repairs, preventive maintenance programs, and spare parts strategy.
• Conduct hands-on training and guidance for the operation of new equipment and processes.
• Author high-quality SOPs and technical documentation to maintain GMP compliance in collaboration with appropriate personnel.
• Develop and execute engineering studies, change controls, deviation investigations, and commissioning protocols.
• Perform risk assessments including FMEA to drive equipment reliability.
• Resolve deviations and ensure timely completion of corrective actions and audit responses.
• Champion site-level projects, improvement initiatives, and support operational excellence efforts.
• Ensure thorough and timely documentation (drawings, specifications, schedules, engineering studies, meeting minutes, etc.) and provide updates to site leadership.
• Remain current on industry and FDA engineering standards and trends.
• Explore, evaluate, and recommend external technologies to improve operations or introduce new capabilities.

Knowledge / Skills Needed

Personal Attributes

Physical Requirements

Education and Experience

Engineer II

BS degree in Engineering or technical discipline.

6+ years of Sterile pharmaceutical experience.

Lead Engineer I / II

BS degree in Engineering or technical discipline.

8+ years of Sterile pharmaceutical experience.

Travel

Travel domestic and international (=10%).

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