We are seeking an experienced Project Engineer to support the delivery of engineering and manufacturing projects in a regulated MedTech environment. The role will involve validation (IQ, OQ, PQ), equipment installation, process improvements, and cross-functional collaboration to ensure projects are delivered on time, within budget, and in compliance with GMP, FDA, and ISO 13485 standards. Key Responsibilities Lead and support end-to-end project execution: scoping, design, vendor management, installation, commissioning, and handover. Prepare, review, and execute URS, FDS, FAT, SAT, IQ, OQ, PQ, and validation reports. Manage CapEx projects, including budgeting, scheduling, and resource allocation. Partner with cross-functional teams (Manufacturing, Quality, R&D, Validation, Supply Chain) to deliver project milestones. Drive process improvement initiatives (yield, throughput, efficiency, cost reduction). Ensure regulatory and quality compliance with GMP, FDA, ISO 13485, and EHS standards. Conduct risk assessments, HAZOP, FMEA, and change controls to ensure safe and compliant project delivery. Support new product introductions (NPI) by validating equipment, processes, and documentation readiness. Provide technical support and troubleshooting for manufacturing systems and processes. Track and report project KPIs, presenting updates to management and stakeholders. Key Requirements Bachelors or master's degree in mechanical, Manufacturing, Process, Biomedical, or related Engineering discipline. 37 years experience in project engineering within MedTech, Pharma, or Biotech manufacturing environments. Proven track record with validation protocols (IQ, OQ, PQ) and equipment qualification. Strong knowledge of GMP, ISO 13485, FDA, and EHS regulations. Experience in automation systems (PLC/DCS/SCADA) and manufacturing equipment is an advantage. Familiarity with Lean Six Sigma, continuous improvement tools, and problem-solving methodologies. Proficiency in MS Project, Minitab. Excellent stakeholder management, vendor coordination, and communication skills. PMP/PRINCE2 or Lean Six Sigma certification (preferred but not mandatory). Skills: IQ OQ PQ Project Management Manufacturing equipment installation validation protocols