Senior API Process Engineer – Lead EPC Pharma Projects

Exyte

Raleigh (NC)

On-site

USD 150,000 - 210,000

Full time

7 days ago

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Job summary

Exyte is seeking a Lead Process Engineer to serve as the technical authority for API small molecule facilities on EPC projects. You will drive process design, dynamic risk assessments, and regulatory compliance across conceptual design through construction, collaborating with multi-disciplinary teams and clients.

Ideal candidates have 10+ years in process engineering, PE license, and a strong background in API processes.

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.
NCEES Record.

Responsibilities

Process Design Leadership: develop/Review PFDs, P&IDs, material and energy balances, and equipment specs for API small molecule facilities.
Project Execution: lead process engineering deliverables, design basis docs, process narratives, and datasheets.
Regulatory & cGMP Compliance: ensure designs meet cGMP, FDA, EMA, and ICH guidelines.
Client Interface: act as the primary process engineering contact for clients and provide technical guidance.
Risk & Safety Analysis: conduct HAZOP and risk assessments with EHS compliance.
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.
Other duties as assigned