Senior API Process Engineer — Small Molecules

Exyte; Raleigh (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading engineering firm is seeking a Lead Process Engineer to serve as a technical authority for process design on EPC projects involving Active Pharmaceutical Ingredient (API) facilities. The role requires 10+ years of process engineering experience, strong leadership skills, and proficiency in process simulation tools. Responsibilities include leading engineering deliverables, ensuring regulatory compliance, and mentoring junior engineers. Candidates should have a Bachelor’s or Master’s degree in Chemical Engineering and a Professional Engineer license.

Qualifications

• 10+ years in process engineering, with at least 5 years in EPC projects.
• Strong background in API small molecule processes and facility design.
• Professional Engineer (PE) License required.

Responsibilities

• Develop and review process flow diagrams and equipment specifications for API facilities.
• Lead process engineering deliverables for EPC projects.
• Ensure compliance with pharmaceutical regulatory requirements.

Skills

Leadership

Communication

Client-facing skills

Process design knowledge

Education

Bachelor’s or Master’s degree in Chemical Engineering

Tools

Aspen Plus

HYSYS

Job description

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

Show your expertise

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

Contact:

You want to be part of the Exyte team? We look forward to receiving your application!
For further questions and information, please do not hesitate to contact Tina Denny [e-mail]

Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.

Exyte US, Inc. is proud to be an Affirmative Action and 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 on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity or expression), national origin, disability status, genetic information, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.