JT562 - SR MANUFACTURING ENGINEER

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, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world‑class manufacturing industry in Puerto Rico & USA.

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 the 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 the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are 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.

Qualifications:

• Bachelor's degree in engineering
• 4+ years of experience in related area
• The ideal candidate independently leads complex equipment lifecycle projects in regulated manufacturing environments—driving procurement support, relocation/installation readiness, IQ/OQ/PQ execution, cleanroom and layout changes, change control updates, and decommissioning—while thriving under tight timelines and shifting priorities
• Experience executing manufacturing 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

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.