Manufacturing Engineer: Lead CAPEX & Process Excellence

MJ Morgan Group; Hershey (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

MJ Morgan Group seeks an experienced Manufacturing Engineer to lead capital projects, drive equipment validation, and pursue continuous improvement in a regulated manufacturing environment. You will collaborate with local and global teams across Production, Quality, Maintenance, and Supply Chain to optimize processes and enhance product quality.

The role requires a technical Bachelor's degree and at least four years of experience in a regulated setting, with hands-on CAPEX, validation (URS,

Qualifications

• Bachelor's degree in a technical field (Mechanical/Electrical/Chemical/Industrial/Manufacturing/Pharmaceutical/Materials).
• Minimum of four years of engineering experience in a regulated manufacturing environment.
• Experience managing CAPEX projects and equipment implementation.
• Knowledge of validation methodologies (URS, FMEA, IQ/OQ/PQ, Process Validation).
• Experience with change control, deviations, CAPA, and Quality Management Systems.
• Working knowledge of cGMP, ISO 9001, and ISO 15378; Lean/Six Sigma and root cause analysis.

Responsibilities

• Lead CAPEX projects and introduce new equipment to improve production efficiency.
• Manage projects from planning through implementation, including scope, schedule, and budget.
• Support equipment qualification and validation activities such as URS, FMEA, IQ/OQ/PQ, and Process Validation.
• Prepare audit-ready documentation in compliance with cGMP, GDP/ALCOA+, ISO standards.
• Lead change control activities and drive continuous improvement to raise OEE.
• Investigate quality events using structured root cause analysis and CAPAs.
• Collaborate with global engineering, Production, Quality, Maintenance, and EHS teams.
• Develop SOPs, preventive maintenance strategies, and training for Production staff.
• Travel to suppliers and company facilities within the U.S. and internationally as needed.

Skills

Project management

Cross-functional collaboration

Problem solving

Communication

Microsoft Office

Education

Bachelor's degree in Mechanical/Electrical/Chemical/Industrial/Manufacturing/Pharmaceutical/Materials Engineering

Tools

SAP

Microsoft Project

SolidWorks

Minitab

Job description

MJ Morgan Group seeks an experienced Manufacturing Engineer to lead capital projects, drive equipment validation, and pursue continuous improvement in a regulated manufacturing environment. You will collaborate with local and global teams across Production, Quality, Maintenance, and Supply Chain to optimize processes and enhance product quality.

The role requires a technical Bachelor's degree and at least four years of experience in a regulated setting, with hands-on CAPEX, validation (URS,