JT562 - SR MANUFACTURING ENGINEER

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA is seeking a talented engineer to join our team. You will relocate, install, commission, and decommission equipment, drive IQ/OQ/PQ, and guide change controls while meeting tight timelines.

Candidates should have a Bachelor's degree in engineering and 4+ years of relevant experience, with strong GMP knowledge and facility layout/utility awareness. This role is based in Puerto Rico & USA.

Qualifications

• Bachelor's degree in engineering is required.
• 4+ years of experience in related area.
• Ideal candidate independently leads complex equipment lifecycle projects in regulated manufacturing environments.
• 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.

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.
• Adapts machine or equipment design to factory and production conditions, including inspection and test requirements.
• Inspects performance of machinery, equipment, and tools to verify efficiency and initiates corrective action.

Skills

Equipment qualification (IQ/CSV/OQ/PQ)

Process validation

GMP compliance

Change control

Education

Bachelor's degree in engineering

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.