Maintenance of EHS management system in line with internal and regulatory requirements ensuring procedures and other documents are kept up to date. Preparation and delivery of training programmes including induction and job specific EHS topics Conducts regular EHS inspections and audits to monitor the effectiveness of the EHS management system and highlight any areas for attention/action. Preparation of EHS reports/metrics for both internal and external stakeholders Leads on EHS issues, stays abreast of evolving standards and technological solutions. Readily shares expertise with others Leads the Emergency Response Programme ensuring the procedures, resources and training are in place to deal with all likely emergency scenarios on site Ensures a robust EHS incident investigation process is in place. Monitors incident trends identifying areas requiring action. Leads investigations as necessary. Assesses the EHS impact of proposed changes to plant, process, equipment etc. and identifies actions to ensure compliance and risk control. Ensures effective risk assessment and risk reduction programmes are in place for the site Monitors EHS legislation ensuring site compliance with current and future requirements as necessary. Maintains waste management requirements and environmental monitoring programme in line with licence requirements Leads EHS projects on site and/or across Ireland UK region as required and supports cross functional teams Collaborates with site leadership to ensure alignment on priority EHS issues and plans to address same. Promotes and supports a culture of accountability and collaboration in relation to safety and environmental performance and expectations Manages spend in line with budget and drives efficiencies and cost savings across EHS service and equipment providers. What you will need Third level qualification (minimum NFQ 8) in EHS, Engineering or Science discipline or equivalent combination of education, training and experience. 6+ years experience in a manufacturing environment or equivalent Ongoing professional development in the area of EHS desirable Exceptional EHS experience and implementation of processes/systems to ensure regulatory compliance and continuous improvement. Ability to interpret EHS/regulatory requirements and lead programmes to meet requirements and bring performance to the next level. Proven strong stakeholder management skills and ability to influence at all levels. Extensive experience in implementing and maintaining EHS management systems. Comprehensive experience in dealing with EHS regulators e.g. H.S.A., E.P.A, Local Councils etc. Relevant professional body qualification or accreditations.
Role Overview As a PLC Automation Engineer, you will be responsible for developing, implementing, and maintaining automation solutions across manufacturing equipment and processes. You will collaborate with cross-functional engineering, quality, and operations teams to ensure reliable, compliant, and efficient production of medical devices. Key Responsibilities Design, program, and troubleshoot PLC-based control systems (Siemens, Allen-Bradley, etc.) for automated equipment. Support installation, validation and commissioning of new automated systems. Develop HMI/SCADA systems for operator-friendly interfaces. Ensure compliance with FDA, ISO 13485, and GxP standards in all automation activities. Collaborate with Manufacturing Engineering, Quality, and Maintenance teams to improve reliability and efficiency. Conduct root cause analysis and resolve automation-related issues with minimal downtime. Manage preventive and predictive maintenance strategies for control systems. Document software, configuration changes, and validation protocols as per regulatory requirements. Support continuous improvement projects (Lean, Six Sigma, Industry 4.0) with automation solutions. Train technicians and operators on equipment functionality and safety protocols. Qualifications & Skills Bachelors Degree in Electrical / Electronics / Mechatronics / Automation Engineering (or related field). 5+ years of experience in PLC automation engineering, preferably in the MedTech, Pharma, or High-Tech Manufacturing sector. Hands-on experience with PLC programming (Siemens S7, Allen-Bradley, Omron, etc.) and HMI development. Knowledge of industrial networks (Ethernet/IP, Profibus, Profinet, Modbus). Excellent troubleshooting, problem-solving, and analytical skills. Ability to work cross-functionally in a fast-paced manufacturing environment. Good communication and documentation skills. Preferred Skills (Nice to Have) Experience with robotics, vision systems. Familiarity with 21 CFR Part 11 compliance for electronic records. Exposure to MES (Manufacturing Execution Systems) and Industry 4.0 technologies. Lean Six Sigma Green Belt or equivalent certification. Skills: HMI PLC Programming Allen Bradley S7 SCADA Control Logic PLC Allen Bradley
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
About the Company NovintiX NovintiX is a fast-growing engineering solutions and digital transformation & technology company that partners with leading Life Sciences and MedTech companies across the US, Ireland, and Europe. We specialise in delivering high-impact digital programmes, engineering services, and talent solutions that support innovation, efficiency, and regulatory compliance. Our clients include some of the worlds top medical device and pharmaceutical brands. Job Summary About the Role We are seeking an experienced Metrology Engineer - CMM with strong proficiency in Calypso software to join our team in Cork, Ireland. This is a fully onsite role, where you will focus on developing, maintaining, and optimising CMM programs to support precision manufacturing and quality assurance. The position requires expertise in dimensional inspection programming and close collaboration with engineering and quality teams. Key Responsibilities Develop, modify, and optimise CMM programs using Calypso software for precision inspection. Create individual CMM programs for new and existing product lines, including Costa Rica-based components. Perform setup, calibration, and operation of CMM machines to ensure accurate measurements. Review 2D/3D engineering drawings, GD&T, and inspection requirements to create inspection routines. Analyse CMM data, interpret results, and provide feedback to quality and engineering teams. Support validation, capability studies, and first article inspections (FAI). Troubleshoot CMM program and equipment issues to maintain production efficiency. Maintain calibration and documentation in compliance with ISO and GMP standards. Collaborate with global teams to standardise programming and inspection practices. Qualifications & Experience Bachelors degree or diploma in Mechanical / Manufacturing / Industrial Engineering (or equivalent technical field). Minimum 5 years of experience as a CMM Programmer, specialising in Calypso software. Proven experience in developing and validating complex CMM programs. Strong understanding of GD&T, 3D modelling, and CAD software (e.g., CATIA, SolidWorks, Creo). Hands-on experience with Zeiss CMM systems and dimensional metrology. Familiarity with GMP, ISO 13485, and regulated manufacturing environments (preferably MedTech). Strong analytical, documentation, and problem-solving skills. Excellent communication and teamwork abilities. Skills: CMM Programmer CMM Specialist Calypso Zeiss CMM Engineer metrology
Role: Calibration Engineer Location: Co Offaly , Ireland Employment Type: Full Time Role Summary We are seeking a highly experienced Calibration Engineering Expert to lead onsite calibration activities across a wide spectrum of mechanical, electrical, and precision instruments. The ideal candidate will be well-versed in ILAC, NABL, and ISO/IEC 17025 standards, capable of independently developing calibration procedures, executing calibrations using master instruments, and maintaining full documentation for compliance and audit readiness. Key Responsibilities Perform calibration of instruments including as few example instrument: Pressure gauges, temperature gauges, load cells Vision systems, rulers, vernier callipers, micrometres Electrical meters, mechanical gauges, and plant assets Utilize traceable master instruments for calibration, ensuring adherence to ILAC/NABL standards Validate equipment performance and ensure measurement accuracy post-calibration Standards & Compliance Apply deep knowledge of: ILAC guidelines for international traceability NABL accreditation protocols ISO/IEC 17025 requirements for calibration labs and field operations Ensure all calibration activities meet regulatory and customer-specific compliance frameworks Documentation & Procedure Development Independently author and maintain: Standard Operating Procedures (SOPs) Work Instructions (WIs) tailored to asset categories Calibration Certificates with uncertainty calculations and traceability Calibration Tag Database for asset lifecycle tracking and scheduling Maintain audit-ready documentation aligned with QMS and regulatory expectations Process Ownership & Continuous Improvement Design and implement calibration schedules and preventive maintenance plans Identify process gaps and propose corrective/preventive actions (CAPA) Support internal and external audits with technical documentation and evidence Customer Coordination & Site Readiness Interface with customer teams for asset access, safety protocols, and downtime planning Train junior technicians or customer staff on calibration best practices and documentation standards Required Skills & Qualifications Diploma/Degree in Instrumentation, Mechanical, Electrical, or Mechatronics Engineering 810 years of hands-on calibration experience in regulated or industrial environments Proficiency in using master calibration tools and software (e.g., Fluke, Mitutoyo, LabView) Strong command over ILAC, NABL, ISO/IEC 17025 standards and documentation protocols Excellent technical writing and stakeholder communication skills Preferred Attributes NABL audit participation or documentation lead experience Exposure to MedTech or Pharma calibration protocols Familiarity with digital calibration tracking systems or ERP integration Skills: Calibration NABL fluke Labview mitutoyo IEC 17025
Job Title: Junior Manufacturing Engineer MedTech Location: Springhill, Ireland Industry: Medical Devices / MedTech Department: Manufacturing Engineering Employment Type: Onsite Role About the Role We are seeking a motivated and detail-oriented Junior Manufacturing Engineer to support daily manufacturing operations within our advanced MedTech production facility. This role is ideal for engineers looking to develop hands-on experience in manufacturing processes, validation, equipment troubleshooting, and continuous improvement within a regulated environment. Key Responsibilities Support production lines by ensuring smooth day-to-day operation and resolving technical issues. Assist in developing, improving, and optimizing manufacturing processes to enhance quality and efficiency. Support equipment setup, calibration, troubleshooting, and maintenance coordination. Participate in process validations (IQ/OQ/PQ), capability studies, and test method validations. Work closely with cross-functional teams (Quality, R&D, Operations, Maintenance). Prepare and update work instructions, SOPs, and process documentation. Assist in root cause analysis (RCA) and contribute to CAPA activities. Support implementation of Lean Manufacturing / Six Sigma improvement initiatives. Ensure compliance with GMP, ISO 13485, and safety regulations. Monitor production performance metrics and contribute to continuous improvement projects. Qualifications & Skills Bachelors degree or diploma in Manufacturing, Mechanical, Biomedical, Industrial, or Process Engineering. 25 years of experience in a manufacturing or engineering role (MedTech/Pharma/Life Sciences preferred). Strong understanding of GMP, ISO 13485, and regulated manufacturing environments. Familiarity with validation, process mapping, and problem-solving tools. Good knowledge of Microsoft Office, basic CAD exposure (SolidWorks/AutoCAD is a plus). Strong communication, teamwork, and documentation skills. Ability to work in a fast-paced production environment with attention to detail. Skills: Lean Manufacturing IQ OQ PQ validation
About the Company NovintiX NovintiX is a fast-growing engineering solutions and digital transformation & technology consultancy that partners with leading Life Sciences and MedTech companies across the US, Ireland, and Europe. We specialise in delivering high-impact digital programmes, engineering services, and talent solutions that support innovation, efficiency, and regulatory compliance. Our clients include some of the worlds top medical device and pharmaceutical brands. Job Summary We are seeking a technically skilledLOTO (Lockout/Tagout) Engineer with a strong maintenance and engineering background to support a leading medical device manufacturing facility. The ideal candidate will be hands-on with equipment such as CNC machines and large vacuum plasma systems, and will be responsible for creating detailed, machine-specific energy control procedures to ensure safe maintenance and servicing operations. This is a highly specialised technical role focused on energy isolation procedure development for complex machinery. It does not involve marking floors, conducting risk assessments, or general EHS administrative tasks. Key Responsibilities Develop and documentmachine-specific energy control procedures (ECPs) for complex manufacturing equipment, including CNC machines and vacuum plasma systems. Identify and isolateall energy sources (electrical, mechanical, pneumatic, hydraulic, thermal, etc.) associated with each machine for safe maintenance. Collaborate with Maintenance, Engineering, and Equipment teams to understand operational specifics and isolation requirements. Support validation and vendor teams by reviewing new equipment for compliance with lockout/tagout safety standards and energy isolation best practices. Ensure procedures meet relevant regulatory and safety compliance standards (e.g., OSHA 1910.147, ISO 13849). Provide technical input during equipment upgrades, installations, and commissioning related to energy isolation. Requirements Bachelors Degree in Engineering (Electrical, Mechanical, or related discipline) or equivalent technical qualification. Minimum of3 years of hands-on maintenance experience in a manufacturing or regulated industry environment. Proven ability to work directly with machinery to identify energy sources and developtechnical LOTO/ECP documentation. Strong working knowledge ofCNC systems, vacuum/plasma equipment, and complex electromechanical systems. Deep familiarity withenergy isolation methods, machine safety protocols, and lockout/tagout best practices. Knowledge of regulatory standards includingOSHA 1910.147 andISO 13849. ???????? ???? ?????????? Opportunity to work on cutting-edge medical manufacturing projects with global visibility. A fast-paced, empowering work environment where your expertise is valued. Access to innovation-driven leadership and a chance to impact large-scale manufacturing strategy. Skills: LOTO EHS Machine Safety Lockout Tagout CMSE Electrical Engineer
