Engineering Designer - 2nd Shift: Process & Compliance

Engineering Resource Group, Inc.; Bridgewater Township (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

Engineering Resource Group, Inc. is recruiting for a 2nd shift Engineering Technician to drive regulatory-compliant process development in pharmaceutical and medical device projects.

The role requires collaboration with Quality, Regulatory, Manufacturing, Supply Chain, and Operations to plan, schedule, and allocate resources, ensuring on-time delivery within scope and budget. The ideal candidate has 4+ years in a regulated GMP environment, strong CAD skills with SolidWorks/AutoCAD, and a solid

Qualifications

• At least 4 years of engineering and project experience in a regulated manufacturing or GMP environment.
• Strong knowledge of engineering design principles and CAD tools (SolidWorks, AutoCAD).
• Familiarity with cGMP, QMSR, ISO 13485 and ISO 14971 quality systems and standards.
• Excellent problem-solving, analytical, and communication skills.

Responsibilities

• Develop project plans, schedules, and resource requirements with cross-functional teams.
• Ensure designs meet regulatory requirements, quality standards, and procedures.
• Support IQ/OQ/PQ commissioning and validation of manufacturing equipment.
• Identify risks and implement mitigation for successful project execution.
• Drive continuous improvement to boost productivity and reduce costs.
• Oversee engineering documentation including specs, drawings, changes, and validation reports.
• Participate in internal and external audits to ensure cGMP and ISO compliance.
• Lead root-cause investigations and CAPA activities.
• Collaborate with Quality, Regulatory, Manufacturing, Supply Chain, and Operations.
• 2nd shift: 2:30-11:00pm.

Skills

Engineering

Project management

Regulatory knowledge

Data analysis

Technical documentation

Problem solving

Tools

SolidWorks

AutoCAD

Job description

Engineering Resource Group, Inc. is recruiting for a 2nd shift Engineering Technician to drive regulatory-compliant process development in pharmaceutical and medical device projects.

The role requires collaboration with Quality, Regulatory, Manufacturing, Supply Chain, and Operations to plan, schedule, and allocate resources, ensuring on-time delivery within scope and budget. The ideal candidate has 4+ years in a regulated GMP environment, strong CAD skills with SolidWorks/AutoCAD, and a solid