Position Title: Director – Engineering & Supply Chain Location: Galway, Ireland (Hybrid) Our client is a leading global healthcare and med‑tech company committed to innovation across the full spectrum of life‑changing solutions. The Galway site plays a key role in manufacturing, engineering and supply‑chain excellence. As Director – Engineering & Supply Chain , you will lead and shape the engineering function within the supply‑chain organisation. Working closely with product development, manufacturing, and global supply‑chain teams, you’ll drive process development, product lifecycle management, cost optimisation and operational excellence. Key Responsibilities Lead process development for new products – embedding manufacturability requirements into new product design and ensuring smooth transition into manufacturing while achieving defined product‑performance criteria. Drive product lifecycle management – lead engineering innovation and process improvements across internal and external manufacturing sites; sustain core products by reducing cost, improving operational efficiency, and maintaining component design integrity. Oversee process engineering – manage internal manufacturing engineering teams to continuously improve processes, enhance compliance, service levels and cost-effectiveness. Direct strategic supply‑chain projects – manage global initiatives ensuring delivery on time, within budget, and aligned with broader supply‑chain strategy. Lead team development – mentor and develop technical and project‑management talent, building capability across the engineering and supply‑chain organisation. Budget ownership – develop and manage the global engineering budget and ensure optimal resource allocation and financial stewardship. Strategic engagement and collaboration – play a key role within the Supply‑Chain Leadership Team, partnering across R&D, manufacturing, and global supply‑chain functions in a matrixed environment. Required Knowledge, Skills & Abilities Strong leadership skills – ability to lead, motivate and develop diverse teams, and build a collaborative culture. Proven project‑management expertise – successful track record of delivering complex, cross‑functional projects. Strategic mindset – ability to anticipate future engineering and business needs, build and execute effective strategies. Excellent interpersonal and relationship‑management skills – able to build strong partnerships with internal and external stakeholders. Education: Bachelor’s degree (BEng or equivalent) in Industrial, Mechanical or Manufacturing Engineering (or related technical discipline). MBA or similar advanced qualification preferred. Certifications: Lean Manufacturing, Six Sigma, APICS, ASQ or PMP desirable. Experience: 10+ years in manufacturing, engineering or supply‑chain roles, ideally within the medical‑device or healthcare industry. Travel: Up to 20%. What’s in it for You Lead a global engineering function within a prestigious healthcare organisation. Drive innovation, efficiency, and product excellence across manufacturing and supply chain. Hybrid working environment with flexibility and autonomy. Join a collaborative, high‑performing culture within Ireland’s med‑tech hub. For further information contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322. #J-18808-Ljbffr
Our client is a world leading supplier of biosecurity & infection control products for the past 50 years. Their dedication to Innovation has been a driving force behind this success. With approx. 1,700 employees across 120 countries, they are committed to driving significant health improvement globally. They are saving lives by improving access to safe drinking water with innovative, cost-effective products. One of their main products is used to disinfect 30 billion litres of water annually. They are currently seeking a Facilities Engineer to join an established team. Reporting to the Business Excellence Lead, this position is responsible for the safe, compliant and efficient management of all site facilities, utilities, and infrastructure supporting tablet manufacturing and packaging operations. This role ensures uninterrupted production through effective maintenance of buildings, warehouses, manufacturing equipment, utilities and site services, while meeting regulatory, health & safety and environmental requirements. Role/Responsibilities Facilities & Utilities Manage site facilities including manufacturing areas, warehouses, laboratories, offices and external infrastructure Oversee critical plant utilities such as: Compressed air, vacuum, gases, and extraction Water systems (e.g. DI water supply) Electrical distribution and backup generator systems Maintenance Management Develop and maintain preventive and predictive facilities maintenance programmes Manage corrective/preventative maintenance activities to minimise downtime Use of CMMS system for purchase orders, asset tracking and documentation Compliance, Quality & Regulatory Ensure facilities and utilities comply with GMP requirements Support audits and inspections in line with business needs Ensure facilities-related SOPs, risk assessments and validation documentation are maintained Health, Safety & Environment (HSE) Ensure safe systems of work, permits and contractor safety controls are in place Manage environmental controls including waste, energy and emissions Support site sustainability, energy efficiency and carbon reduction initiatives Projects & Capital Works Lead or support facilities-related capital projects and upgrades Coordinate equipment installations, layout changes and building works as required Manage budgets, schedules, contractors and commissioning activities site-wide Ensure projects are delivered safely, on time and within approved budget People & Contractor Management Manage external contractors and service providers site-wide Foster strong collaboration with Production, Quality and EHS teams Provide training to new and existing personnel as required Financial & Performance Management Help to prepare and manage facilities budgets and forecasts Control operational costs while maintaining compliance and reliability Track KPIs such as uptime, fuel and energy usage across the plant Participate in training to enhance your role as necessary Qualifications/ Experience Certificate or equivalent trade qualification in Engineering, Facilities Management or a related discipline Proven experience managing facilities in a regulated manufacturing environment Strong knowledge of GMP, health & safety and environmental regulations Experience managing utilities, HVAC and maintenance systems Lean / Six Sigma or continuous improvement experience For further information please contact: Karen Shiel on 087 7452487 or send CV to karen.shiel@lifescience.ie #J-18808-Ljbffr
Life Science Recruitment is looking for a Facilities Engineer in Wexford, Ireland. This role is crucial for managing site facilities and utilities, ensuring compliance with GMP and health & safety regulations. Key responsibilities include developing maintenance programs and leading capital projects. The ideal candidate will have a certificate in Engineering or Facilities Management and proven experience in a regulated manufacturing environment. Join a company dedicated to saving lives through innovative water safety solutions. #J-18808-Ljbffr
Life Science Recruitment is seeking a Quality Assurance specialist for an award-winning Pharmaceutical organization in Carlow, Ireland. The successful candidate will provide quality oversight for the introduction of new products and manage supplier performance metrics. A Bachelor's degree in a related Science discipline, along with 3-5 years of quality experience in a pharmaceutical environment, is required. Familiarity with regulatory requirements and cGMP is preferred. This role offers an opportunity to engage in compliance initiatives and quality improvement projects. #J-18808-Ljbffr
Regulatory Affairs Manager – Medical Devices We are supporting a growing medical device manufacturer in the appointment of a Regulatory Affairs Manager to build and lead their regulatory function. This is a key hire with full responsibility for regulatory strategy and execution, including CE marking under EU MDR 2017/745 for a portfolio of Class II medical devices. Key Responsibilities Lead end‑to‑end CE marking activities under EU MDR 2017/745 Define product classification and conformity assessment strategies Build and maintain an ISO 13485‑compliant Quality Management System Prepare and maintain technical documentation (Annex II/III) Manage Notified Body selection, audits, and ongoing relationships Develop clinical evaluation documentation and PMS activities Act as the primary contact for regulatory authorities and submissions Support future global regulatory strategy (e.g. FDA 510(k)) Requirements 4–7 years’ experience in medical device regulatory affairs Strong working knowledge of EU MDR 2017/745 Experience taking a Class IIa or IIb device through MDR from scratch Knowledge of ISO 13485, ISO 14971, and clinical evaluation processes Experience building or developing a Quality Management System Ability to work autonomously in a fast‑paced environment Implantable or Class II device experience Exposure to global regulatory pathways (e.g. FDA 510(k)) Experience with EUDAMED and UDI systems Background in international manufacturing environments What’s on Offer Fully remote role within Ireland Opportunity to build and own the regulatory function High level of visibility and influence within the organisation Strong growth potential as the company scales #J-18808-Ljbffr
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Key Responsibilities Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties. Provide QA oversight to support Analytical, Warehouse and Facilities Management, including deviations, Root cause analysis, CAPAs and change controls Participate as a functional expert in the cross‑functional team responsible for introducing products and materials at Carlow. Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight. Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross‑functional forums as needed. Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used at Carlow. Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings. Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups. Education and Experience A Bachelor's degree or higher in a related Science discipline is preferred. A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices. Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred. Familiarity with sterile filling processes and equipment. #J-18808-Ljbffr
Life Science Recruitment is seeking a Regulatory Affairs Manager to lead regulatory strategy and execution for a growing medical device manufacturer. This fully remote role in Ireland will involve end-to-end CE marking activities, building a compliant Quality Management System, and acting as the primary contact for regulatory authorities. The ideal candidate has 4-7 years of relevant experience and strong knowledge of EU MDR 2017/745. This position offers significant influence and growth potential within the company. #J-18808-Ljbffr
Benefits Top salary, bonus, pension, healthcare and 4 day week Role As a Senior Supervisor will lead and manage manufacturing operations to ensure efficient production of high-quality medical devices in compliance with regulatory standards. This role involves overseeing production teams, driving continuous improvement, collaborating cross-functionally to meet business goals, and ensuring day-to-day production safety, quality, delivery, and cost targets are met. On-site role in a cleanroom and controlled manufacturing environment. Responsibilities Lead daily production activities, ensuring safety, quality, delivery, and cost targets are met. Manage and develop production supervisors, team leads, trainers, and operators, fostering a high-performance culture. Responsible for production co-ordination to meet customer demand. Ensure compliance with ISO 13485, FDA, and other relevant regulatory standards. Collaborate with Engineering, Quality, and Supply Chain to resolve production issues and implement process improvements. Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities, and the company. Monitor KPIs and drive continuous improvement initiatives using Lean and Six Sigma methodologies. Education and Experience Requirements Bachelor’s degree in Engineering, Manufacturing, or related field. 5+ years of experience in medical device or regulated manufacturing industry. Strong knowledge of GMP, ISO 13485, and FDA regulations. Proven leadership and team development skills. Experience with Lean Manufacturing, Six Sigma, and continuous improvement tools. Excellent communication, problem-solving, and organizational skills. #J-18808-Ljbffr
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The Program Manager – AVI Lines Operational Readiness is a senior delivery role providing leadership and execution oversight for Operational Readiness activities associated with the AVI inspection lines SI02 and SI03 through qualification and Performance Qualification. The role operates within an established and experienced project environment and is accountable for ensuring readiness activities are planned, integrated, governed, and executed to support successful transition to routine operations. This role will lead and coordinate Operational Readiness execution for AVI inspection lines SI02 and SI03 through PQ, ensuring people, process, systems, documentation are prepared to support qualification and operational handover. The role ensures readiness activities are integrated with project execution and qualification plans while maintaining compliance, governance, and delivery discipline. Duties Own the Operational Readiness strategy and execution for AVI inspection lines SI02 and SI03 through qualification and PQ. Integrate readiness activities with capital project execution, commissioning, and validation milestones. Provide programme level oversight of readiness workstreams including documentation, training, change control, validation interfaces, MES readiness, and operational handover. Act as the primary Operational Readiness interface between Capital Projects and Operations for the AVI scope. Maintain integrated readiness plans, trackers, and dashboards aligned with company’s master schedule. Identify readiness risks, gaps, and dependencies and drive mitigation through governance. Provide clear readiness input to programme and senior leadership governance forums. Promote a strong safety culture across readiness execution. Ensure all Operational Readiness activities conform to cGMP requirements. Ensure scope and financial discipline in line with site governance. Support inspection readiness and regulatory interactions as required. Education and Experience Technical degree or equivalent experience in Engineering, Science, or Operations. 5 to 8 years’ experience in Pharmaceutical, Biotechnology, or Life Sciences manufacturing. Experience operating within GMP regulated environments Strong programme and project management capability within a GMP manufacturing environment. Experience coordinating complex cross functional delivery teams. Strong execution focus with structured planning and tracking discipline. Systems experience: Change Control & Document Management Systems, SharePoint and Microsoft 365 collaboration tools or Smartsheet equivalent programme tracking tools. If interested in this posting please feel free to contact Avishek Singh at Avishek.singh@lifescience.ie for further information. #J-18808-Ljbffr
Life Science Recruitment is seeking a qualified professional for a position focused on developing single use systems within a leading biopharmaceutical organization in Dublin. The role requires a Bachelor's or Master's degree along with relevant experience in aseptic manufacturing technologies. Key responsibilities include process development expertise, risk assessment leadership, and troubleshooting drug product processing technologies. The ideal candidate will have strong leadership and communication skills, as well as knowledge of FDA and EU regulations. #J-18808-Ljbffr
