Lead Process Engineer

Exyte GmbH•Raleigh, NC

About The Position

The Lead Process Engineer will serve as the technical authority for process design and execution on EPC projects involving Active Pharmaceutical Ingredient (API) facilities, with a focus on small molecule drug substances. This role will lead process engineering activities across all project phases—conceptual design, FEED, detailed engineering, and construction insuring compliance with client specifications, regulatory standards, and project objectives.

Requirements

Education: Bachelor’s or Master’s degree in Chemical Engineering.
Experience: 10+ years in process engineering, with at least 5 years in EPC project execution for pharmaceutical or chemical facilities.
Strong background in API small molecule processes and facility design.
Professional Engineer (PE) License
Nation Council of Examiners for Engineering and Surveying (NCEES) Record
Technical Skills: Proficiency in process simulation tools (Aspen Plus, HYSYS) and engineering standards.
Knowledge of cGMP, regulatory compliance, and cleanroom design principles.
Soft Skills: Strong leadership, communication, and client-facing skills.
Ability to manage multiple priorities in a fast-paced EPC environment.

Nice To Haves

Professional Engineer (PE) License preferred
Nation Council of Examiners for Engineering and Surveying (NCEES) Record preferred
Experience with modular construction and advanced manufacturing technologies
Familiarity with ISPE guidelines and QbD principles
Prior involvement in large-scale greenfield or brownfield pharmaceutical projects
Prior experience in consulting engineering

Responsibilities

Process Design Leadership: Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), material and energy balances, and equipment specifications for API small molecule facilities.
Project Execution: Lead process engineering deliverables for EPC projects, including design basis documents, process narratives, and datasheets.
Regulatory & cGMP Compliance: Ensure designs meet pharmaceutical regulatory requirements, including cGMP, FDA, EMA, and ICH guidelines.
Client Interface: Act as the primary process engineering contact for clients, providing technical guidance and ensuring alignment with project goals.
Risk & Safety Analysis: Conduct HAZOP, risk assessments, and ensure compliance with EHS standards.
Construction & Commissioning Support: Provide field engineering support during installation, commissioning, and start-up phases.
Team Leadership: Mentor junior engineers and coordinate with multi-disciplinary teams (mechanical, electrical, automation) to deliver integrated solutions.
Other duties as assigned

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