Lead Process Equipment Engineer

Job Description

The Lead Process Equipment Engineer is accountable for driving optimal equipment design, strategic reliability practices, and continuous improvement initiatives to consistently exceed customer expectations. Serves as the SME on process equipment and demonstrates deep functional knowledge of equipment operation across polymer, sterile, and oral solid dosage (OSD) pharmaceutical processes. Spearheads and contributes to continuous improvement projects aligned with commercial and clinical production needs. The role requires troubleshooting automated equipment, implementing equipment improvements, and ensuring compliance with regulatory documentation and operational protocols.

Job Description:

• 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 consistent updates to site leadership.
• Remain current on industry and FDA engineering standards and trends.
• Explore, evaluate, and recommend external technologies to improve current operations or introduce new capabilities.

Knowledge/Skills Needed:

• Advanced 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
• Strong capabilities in process equipment design/specification, sizing, statistics, process control and operational risk analysis
• Skilled in hands-on instrumentation installation and equipment troubleshooting.
• Proven ability to maintain and optimize manufacturing systems, utilities, and process equipment.
• Comprehensive knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
• In-depth knowledge of sterile pharmaceutical operations, process equipment and utility qualifications.

EDUCATION AND EXPERIENCE:
Lead Engineer I/II

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 8+ years of manufacturing experience or technical experience.

Preferred Qualification:

• 8+ years of Sterile pharmaceutical experience.
• Experienced working on (and coordinating) multiple projects in an orderly and efficient manner while consistently meeting established deadlines.
• Experienced working successfully across functions to meet company objectives.

Travel

Travel domestic and international (<10%)