QUALITY CONSULTING GROUP, a leader in the 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
- Process Validation
- 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
Skills Required
- Bachelor's degree in engineering
- 4+ years of experience in a related area
- Experience leading complex equipment lifecycle projects in regulated manufacturing environments
- Experience with equipment moves, installations, commissioning, startup, and decommissioning
- Knowledge of facility utilities, equipment integration, and manufacturing readiness activities
- Experience with equipment qualification, including IQ, CSV, OQ, and PQ
- Experience with process validation, cleaning validation, and cleanroom qualification
- Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state
- Experience supporting manufacturing layout changes, facility modifications, and material and personnel flow assessments
- Ability to evaluate facility, utility, and environmental requirements for regulated manufacturing operations
- Availability for first shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
