Senior Manufacturing Engineer: Equipment Moves & Validation

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a seasoned Engineer to lead equipment lifecycle projects in regulated manufacturing environments in Puerto Rico and the mainland U.S. You will oversee relocation, installation, IQ/OQ/PQ, commissioning, decommissioning, and change control to ensure compliant, efficient production.

The role requires a Bachelor's in engineering, 4+ years of related experience, strong knowledge of GMP, process validation, and facility utilities, and willingness to work 1st

Qualifications

• Bachelor's degree in engineering.
• 4+ years of experience in related area.
• Leads complex equipment lifecycle projects in regulated environments—driving procurement support, relocation/installation readiness, IQ/OQ/PQ execution, cleanroom and layout changes, change control updates, and decommissioning.
• Experience executing equipment moves, installations, commissioning, startup, and decommissioning activities.
• Knowledge of facility utilities, equipment integration, and manufacturing readiness activities.
• Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning validation, and cleanroom qualification.
• Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state following equipment or facility changes.
• Experience supporting manufacturing layout changes, facility modifications, material and personnel flow assessments.
• Ability to evaluate facility, utility, and environmental requirements for regulated manufacturing operations.
• Availability for 1st shift

Responsibilities

• Equipment Relocation, Installation & Decommissioning
• ProcessValidation
• Manufacturing Process & Facility Change Management
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions; may incorporate inspection and test requirements into production plan.
• Inspects performance of machinery, equipment, and tools to verify efficiency; investigates and initiates corrective action of problems to ensure product quality.
• Develops manufacturing processes applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Skills

Project leadership

GMP knowledge

IQ/OQ/PQ execution

Process validation

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ tools

Job description

Quality Consulting Group, LLC is seeking a seasoned Engineer to lead equipment lifecycle projects in regulated manufacturing environments in Puerto Rico and the mainland U.S. You will oversee relocation, installation, IQ/OQ/PQ, commissioning, decommissioning, and change control to ensure compliant, efficient production.

The role requires a Bachelor's in engineering, 4+ years of related experience, strong knowledge of GMP, process validation, and facility utilities, and willingness to work 1st