Project Engineer

Novintix Technologies Limited; Cork; On-site; EUR 70,000 - 100,000; Full time

Job summary

Novintix Technologies Limited in Cork, Ireland, seeks an experienced Project Engineer to lead and support end-to-end project execution in MedTech manufacturing, from scoping and design to installation, commissioning and handover.

The role requires hands-on validation with IQ/OQ/PQ protocols, GMP/ISO 13485/FDA knowledge, and strong vendor coordination. You will manage CapEx, drive continuous improvement, and ensure safe, compliant project delivery.

Qualifications

• Bachelor's or master's degree in mechanical, manufacturing, process, biomedical, or related engineering.
• 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 TPBN1_IJ

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.

Skills

IQ/OQ/PQ

Project Management

Manufacturing Equipment

Lean Six Sigma

MS Project

Minitab

Vendor Coordination

Stakeholder Management

Communication Skills

Education

Bachelor's or Master's in Mechanical/Manufacturing/Process/Biomedical Engineering

Tools

MS Project

Minitab

SCADA/PLC

Job description

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 TPBN1_IJ