Process Engineering Manager - Regulated

Job DescriptionJob Description

Title: Process Engineering Manager – Regulated Manufacturing
Location: North Carolina
Type: Full-Time
Salary: $150,000 + Bonus

Role Overview

We are seeking an experienced Process Engineering Manager to lead engineering initiatives for a high-volume, regulated manufacturing facility. In this role, you will oversee process optimization, capital projects, and utility system improvements, ensuring compliance with strict quality, safety, and operational standards. You'll manage a multidisciplinary team of engineers, designers, and contractors while driving innovation and operational excellence.

Key Responsibilities

Engineering Leadership & Process Optimization

• Provide day-to-day engineering support for production processes and equipment.
• Drive process improvements, equipment upgrades, and utility system enhancements.
• Lead startups and commissioning for new processes and manufacturing technologies.

Project & Capital Management

• Manage design, procurement, and installation for equipment and facility expansions.
• Develop and oversee departmental and capital budgets.
• Prepare capital project approvals, requisitions, and purchase orders.

Compliance & Documentation

• Ensure adherence to cGMP, OSHA, and other regulatory or industry standards.
• Author, review, and approve engineering documentation, change controls, and risk assessments.
• Partner with validation teams to qualify processes and close out audit observations.

Technical Expertise

• Review and approve technical packages for key process systems (filling, packaging, sterilization, cleaning systems).
• Provide troubleshooting support for manufacturing equipment and utilities.

Team Development & Collaboration

• Recruit, train, and mentor engineering staff, interns, and contractors.
• Partner cross-functionally with operations, maintenance, and quality teams to support site goals.
• Align engineering projects with ISO 14001, ISO 50001, and ISO 45001 requirements

Qualifications:

• Bachelor's degree in engineering or related technical discipline (or equivalent experience).
• 5+ years of engineering or manufacturing experience in a regulated industry (e.g., food & beverage, medical devices, aerospace, chemicals, or similar).
• Knowledge of manufacturing processes, automation/controls (PLCs, HMIs), utilities, HVAC, and piping systems.
• Proficiency in AutoCAD, machine design, and reading P&IDs.
• Strong project management and leadership skills.

Work Environment

This is a hands-on role with a blend of office and production floor presence. Occasional off-hours work may be required to support production schedules and critical engineering activities.