Lead Process Engineer - equipment - 13643

Lead Process Equipment Engineer

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. This position will collaborate cross-functionally with teams such as Engineering, Reliability, Manufacturing, and Quality to strengthen equipment reliability and proactively mitigate supply chain risk.

- 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.

- 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.

- Ability to author high-quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS).

- Skilled in navigating matrixed cross-functional teams across engineering, quality, and operations.

- Strong presentation abilities with both technical and leadership audiences.