About the role
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