Lead API Process Engineer – EPC Projects

Exyte; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Exyte US, Inc. is seeking a Lead Process Engineer to own process design and execution for API small molecule facilities within EPC projects.

You will guide process engineering activities across conceptual design through construction, ensuring alignment with client specs and regulatory standards. The role requires a PE license, 10+ years in process engineering with EPC pharma/chemical experience, and strong leadership for cross-disciplinary teams.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering.
• 10+ years in process engineering, with at least 5 years in EPC project execution for pharmaceutical or chemical facilities.
• Professional Engineer (PE) license and NCEES Record.
• Proficiency in process simulation tools and knowledge of cGMP/regulatory compliance.

Responsibilities

• Lead process engineering deliverables for EPC projects, including design basis documents, process narratives, and datasheets.
• Develop and review PFDs, P&IDs, material and energy balances, and equipment specs for API small molecule facilities.
• Ensure designs meet regulatory requirements (FDA/EMA/ICH) and client specifications.
• Act as primary process engineering contact for clients and coordinate with multi-disciplinary teams.
• Conduct HAZOP and risk assessments and ensure EHS standards.
• Provide field engineering support during installation, commissioning and start-up phases.
• Mentor junior engineers and coordinate with mechanical, electrical and automation teams.
• Other duties as assigned.

Skills

Process design leadership

Project execution

Regulatory & cGMP compliance

Client interface

Risk & safety analysis

Construction & commissioning support

Team leadership

Education

Bachelor’s or Master’s degree in Chemical Engineering

Tools

Aspen Plus

HYSYS

Job description

Exyte US, Inc. is seeking a Lead Process Engineer to own process design and execution for API small molecule facilities within EPC projects.

You will guide process engineering activities across conceptual design through construction, ensuring alignment with client specs and regulatory standards. The role requires a PE license, 10+ years in process engineering with EPC pharma/chemical experience, and strong leadership for cross-disciplinary teams.