Senior Process Engineer

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

Discover your exciting role

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.

Explore Your Tasks And 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

Minimum 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.

Preferred

• 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

Exyte US, Inc. is proud to be an Equal Employment Opportunity employer that is committed to celebrating diversity and supporting an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance. We prohibit discrimination and harassment of any kind based based on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity), national origin, disability, genetic information, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.