Apply on Employer Site

Exyte · 7 hours ago

Lead Process Engineer

Raleigh, NC

Full-time

Onsite

Lead/Staff

10+ years exp

Exyte is a company focused on engineering solutions for the pharmaceutical industry, and they are seeking a Lead Process Engineer to serve as the technical authority for process design and execution on EPC projects. The role involves leading process engineering activities, ensuring compliance with regulatory standards, and mentoring junior engineers throughout the project phases.

Civil Engineering

No H1B

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

Qualification

Process Design LeadershipAPI small molecule processesRegulatory complianceProcess simulation toolsProfessional Engineer (PE) LicenseRisk & Safety AnalysisTeam LeadershipCommunication skills