Lead Process Engineer-EquipmentAlkermes • Wilmington, OH, US
Lead Process Engineer-Equipment
Alkermes • Wilmington, OH, US
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job_description.job_card.job_descriptionAdvanced understanding of mechanical and chemical engineering principles applied to complex process systems and equipment. In-depth knowledge of automated control systems and integration into pharmaceutical manufacturing operations. Solid knowledge of computer systems and software applications supporting automation and data-driven decisions. Process equipment design / specification, sizing, statistics, process control and operational risk analysis. Hands-on instrumentation installation and equipment troubleshooting. Ability to maintain and optimize manufacturing systems, utilities, and process equipment. Knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. Knowledge of sterile pharmaceutical operations, process equipment and utility qualifications. Ability to author technical protocols / reports (Engineering Studies, Validation protocols, equipment specifications, SOPs). Experience navigating matrixed cross-functional teams across engineering, quality, and operations. Strong presentation abilities with technical and leadership audiences. Exceptional communication, coordination, and organizational skills. Ability to self-manage and prioritize workload. Ability to react quickly to understand and solve problems. Positive attitude and adaptability to changing priorities. Fosters collaborative relationships within and across teams. Skilled in design, installation, start-up, and commissioning of typical pharmaceutical mechanical systems. Ability to operate all types of production equipment and manage conflicts constructively. Occasional periods of repetitive motion. Ability to gown in an aseptic manner for clean room operations. Walking, lifting, pushing and pulling carts, reaching, climbing, and bending as required. Ability to read, understand, and follow company SOP guidelines. Steel-toe shoes, scrubs, and other PPE as required; ability to stand in steel-toed shoes for 2-3 hours at a time. Basic Qualifications : 6+ years of manufacturing or technical experience. Preferred Qualifications : Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. Experience coordinating multiple projects with deadlines. Strong written and verbal communication skills and cross-functional collaboration. Basic Qualifications : 8+ years of manufacturing or technical experience. Preferred Qualifications : Experience coordinating multiple projects with deadlines. Cross-functional collaboration across functions to meet objectives.
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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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