Engineering Designer – 2nd shift

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

• Permanent position for a 2nd shift Engineering Technician ensuring pharmaceutical and medical device process development projects are completed on time and within scope and budget while meeting all technical, quality, regulatory, and safety requirements.
• Develop project plans, schedules, and resource requirements by collaborating with Quality, Regulatory, Manufacturing, Supply Chain, and Operations teams.
• Ensure designs meet applicable regulatory requirements, quality standards, and company procedures.
• Provide technical expertise for equipment selection, process design, automation, and facility improvements.
• Engage with installation, commissioning, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes.
• Identify project risks and implement mitigation strategies to ensure successful execution.
• Drive continuous improvement initiatives focused on productivity, cost reduction, and process optimization.
• Support root cause investigations, non-conformance resolution, and corrective and preventive actions (CAPA).
• Oversee engineering documentation including specifications, drawings, change controls, and validation reports.
• Participate in internal and external audits to ensure compliance with cGMP, FDA QMSR, ISO 13485, and ISO 14971 risk management requirements.
• At least 4 years of engineering and project experience in a regulated manufacturing or GMP environment.
• Strong knowledge of engineering design principles and a good working knowledge of Solid Works and AutoCAD.
• Knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 quality systems, and applicable regulatory standards.
• Proficiency in project planning tools, data analysis and technical documentation.
• Self-starter with excellent interpersonal skills, time management abilities to manage multiple priorities simultaneously, ability to take project ownership, and strong analytical, problem-solving, and decision skills making skills. 2nd shift position: 2:30-11:00pm.