Stratford Solutions Inc.
Process Engineering Manager - Regulated
Stratford Solutions Inc., Charlotte, North Carolina, United States, 28201
Job Description
Job 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.
Job 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.