Senior QA Validation Specialist (hybrid) RK4761 Contract 12 months Dublin Were 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. Duties: Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations. Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents Review of executed validation documents and reports Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Perform all activities in compliance with company safety standards and SOPs In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role Educational and Experience University degree in an Engineering or Science-related discipline (preferred). Over 6 years of relevant experience in the pharmaceutical or biotechnology industry Understanding of principles of Validation and New Product Introduction Experience in change control, non-conformance, corrective and preventative actions, and validation practices. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Job title: Senior Quality Engineer Location: Glasnevin, Dublin 11 (on site role) Benefits: Top salary, Bonus, pension and Healthcare Company: My client are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each others opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: To drive the day to day implementation of the QMS with a focus on continuous improvement. Support manufacturing, supply chain and design assurance activities. Represent the quality function cross functionally Experience required: - Bachelors Degree in Engineering, Science or related field - 5+ years experience in medical device quality/design assurance role - Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards Responsibilities: - Drive the day to day implementation of the QMS - Lead QMS continuous improvement activities - Ensure delivery of overall quality strategy & support achievement of the business quality objectives - Collaborate with wider team to ensure necessary QA activities are planned, executed and documented - Interpret relevant standards and ensure company meets requirements - Develop and review test specifications, part specifications & design specifications with cross functional team - Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation and change control - Provide practical QA and Design Assurance expertise Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on OR Benefits: Bonus, pension and healthcare
Learning Systems Lead Our client, a global pharma company are currently recruiting for a Learning Systems Lead to join their team on a permanent basis. As Learning Systems Lead you will support the integration and optimisation of learning technologies and systems to meet regulatory, compliance, and scientific training needs. You will partner with site and global teams to harness data analytics, assess training effectiveness, and inform continuous improvement, while supporting the adoption of innovative digital learning solutions. This role ensures that learning and development initiatives are measurable, adaptive, and aligned with both site and global standards. Responsibilities Support the integration and optimization of learning technology platforms and systems Assist in the digital transformation of learning and data-driven decision-making Partner with site and global teams to implement innovative learning solutions Support the design and maintenance of scalable, competency-based curricula and adaptive assignment frameworks Utilize data analytics to assess training effectiveness and identify competency gaps Collaborates with scientific, manufacturing, and quality teams to enhance training outcomes and compliance Contributes to continuous improvement and future innovation in a highly regulated environment Requirements Bachelors degree Experience in regulated or GMP environments 2+ years experience in training, facilitation, or learning & development Strong communication, collaboration, and organizational skills. Proficient with MS Office Ability to work across multiple stakeholders and influence without authority. Experience in regulated or GMP environments Familiarity with LMS systems and learning data analytics tools Knowledge of instructional design and adult learning principles Project management and problem-solving skills For more information please contact Sinéad Cullen on or
We’re currently recruiting for an exciting opportunity with an award-winning diagnostics organization based in Kilkenny. 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. Duties Install new equipment and support validation activities. Perform scheduled preventive maintenance and diagnose/troubleshoot equipment faults. Carry out repairs and maintenance across mechanical, pneumatic, and electrical systems. Take the lead in resolving maintenance or process-related issues. Read and interpret technical blueprints and schematics. Train manufacturing operators in production processes. Identify and implement corrective actions for process or equipment-related issues. Education & Experience Minimum Level 6 qualification (Trade certification or third-level equivalent). Proficiency in both electrical and mechanical systems is preferred. Strong technical aptitude with effective fault-finding and problem-solving abilities. If interested in this posting please feel free to contact Seán McCarthy on or for further information. #J-18808-Ljbffr
Director of Regulatory Affairs – Medical Device Start-Up – Galway Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally. The Opportunity We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the company’s global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly. Key Responsibilities Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines. Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations. Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities. Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies. Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making. Support due diligence and partnership activities through regulatory assessments and strategy development. About You Minimum of 10 years’ experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role. Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential). Strong understanding of the global regulatory environment, including emerging markets. Ability to think strategically while executing detailed regulatory plans. Exceptional leadership, communication, and stakeholder management skills. Comfortable operating in a fast-paced, high-growth, entrepreneurial environment. Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous. What’s on Offer The chance to be a key architect of the company’s regulatory success during an exciting growth phase. A senior leadership role with real influence across the business. Competitive salary, equity participation, and an attractive benefits package. An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits. If interested in discussing further please contact James Cassidy or call in confidence #J-18808-Ljbffr
Learning & Performance Training Associate (hybrid) RK4759 Contract 12 months Dublin Were 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. Duties: Training needs analysis: Identify and assess the training and development needs of employees and departments through observation, consultation with managers, and analysis of performance metrics. Assess training impacts of new and updated procedures to ensure adequate supplementary training and appropriate assignment of training. Program development: Support Design, development, and update of engaging and impactful training materials for classroom and on-the-job training. Content includes new hire orientation, standard operating procedures (SOPs), and cross-training initiatives. Training delivery: Support delivery of L&P training programs by ensuring communications, learner attendance, and logistical support for Instructors, along with scheduling and monitoring of programs. Compliance and Audit Support: Work with compliance team to ensure appropriate training support of Internal and External Audits and Inspections. Use the company's Learning Management System (LMS) to provide reports to support site and cross functional adherence to KPIs. Ensure all training practices comply with internal quality standards and external regulatory requirements. Stakeholder collaboration: Partner with other functions, such as Manufacturing, Quality, and Environmental, Health, and Safety (EHS), to support and lead training initiatives. Continuous improvement: Drive continuous improvement in training systems, materials, and processes by staying current with industry best practices. Educational and Experience Bachelor's or Associate's degree in a relevant discipline such as Education, Science, or Manufacturing is preferred. Prior experience in a training role within a manufacturing or industrial environment is typically required (e.g., medical device, pharmaceutical) Comprehensive understanding of relevant regulations and standards, such as Good Manufacturing Practices (GMP). Experience with a Learning Management System (LMS) and proficiency in Microsoft Office applications, and AI tools. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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.AsDirector 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, youll 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:Bachelors 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%. Whats 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 Irelands med-tech hub . For further inforamation contact James Cassidy or call in confidence
Our client is a leading supplier of lab equipment & consumables to the Pharmaceutical Sector across Ireland. They currently have a requirement for a Materials Controller who will be based on site in Limerick in a large Biopharma plant with 9 other colleagues. The Materials Controller will be responsible for carrying out a number of tasks on site, all of which can include but not limited to, inventory management & metric review, purchasing, receiving, chemical tracking, storeroom management, product delivery and general customer services activities. Role/Responsibilities Ensure that stock is prepared and maintained for detailed storing, perform daily stock cycle counts, and keep accurate records on inventory and check for any discrepancies Order consumable replenishment items online and deliver goods to customer locations. Continuously monitor inventory consumption levels and flag reports on a weekly basis Receive inbound deliveries and account for all defective or damaged products and follow up with appropriate corrective action; move and store stock by hand or machines Glass & cabinet washing; glass, solvents & samples disposal as per expiry date Recycling of all packaging materials as per customer and our cleints policies Identifying opportunities for improved services and implementing them Act as a point of contact for audits relating to inventory programs Education / Experience Leaving certificate 1+ years experience in material handling/inventory replenishment, warehousing or customer service Stores/Warehouse and stock management experience is an advantage Proven excellent customer service focus and ability to work collaboratively with your team Excellent attention to detail and corresponding outstanding communication skills GxP know-how would be desirable MS Office proficiency (Outlook, Word, Excel, PPT) Valid driving license For further details please contact: Karen Shiel on or send CV in confidence to Skills Materials Controller Inventory Management GMP #J-18808-Ljbffr
Quality Assurance Specialist (hybrid) RK1559 Contract 6 months Dublin Were currently recruiting for an exciting opportunity with a leading global logistics organization supporting the pharmaceutical and life sciences sector in Dublin. This is an excellent role for anyone looking to join a world-class multinational known for its high standards and strong reputation in quality and compliance. Duties: Manage the preventative maintenance schedule and liaising with contractors to arrange site visits, follow up on reports and ensure appropriate documentation is received and internal logs are maintained. Ensuring all appropriate qualifications are performed for activities undertaken under the WDA, e.g. temperature mapping, monitoring, validation, equipment validation, system validation, transport validation. Liaising with contractors to arrange validations and site visits, peer reviewing protocols and reports and ensuring appropriate documentation is received and internal logs are maintained. Ensuring that the warehouse/facility is successfully operated in keeping with GDP, including temperature management, and that any excursions/issues are addressed and reported on a timely basis (CAPAs closed out correctly). Drafting change controls and risk assessments in line with current EU and HPRA guidelines to ensuring a comprehensive and effective Quality Risk Management/Change Control & CAPA procedures is in place Drafting and updating Quality Technical Agreements and supporting with the third-party supplier approval process Support with managing the daily interfaces with supply chain, customer services and facility management to ensure all medicinal product receipts and deliveries are made in keeping with GDP best practice and per SOPs. Ensure that all records are completed in real time and to a high standard in keeping with SOPs/Quality Systems. Assist with updating operational work instructions and updating SOPs Assist the quality team in ensuring that initial and continuous training programmes are updated, implemented and maintained. Ensure that all relevant complaints are investigated in a timely manner. Ensure that such complaints are documented and followed up to ensure that all appropriate corrective actions are taken Educational and Experience University degree in an Engineering or Science-related discipline (preferred). Over 2 years of relevant experience in the pharmaceutical or biotechnology industry Experience with handling deviations, CAPAs, risk management, change control, validations, document authoring and control, temperature monitoring and temperature control Familiar with EU GDP Regulation (2013/C/343/01) If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Manufacturing Technician (MedTech Production Line) Join an innovative and growing Irish-based Medical Device Company specializing in pioneering therapies for the Cardiovascular/Surgical sector. This organization is focused on advancing patient care with unique, proprietary technology and offers an excellent environment for technical professionals seeking career growth and are seeking an experienced and proactive Manufacturing Technician to provide critical, hands-on technical support for a highly regulated production line. You will be instrumental in ensuring product quality, minimizing downtime, and driving continuous improvement projects using Lean and Six Sigma methodologies. This role is ideal for a versatile technician who thrives in a fast-paced, high-compliance manufacturing environment. Key Responsibilities This role is focused on the practical, day-to-day excellence of the manufacturing line: Production Support: Serve as the primary technical contact for the manufacturing line, providing prompt support to resolve stoppages, anomalies, and general technical issues related to equipment, tooling, process, or materials. Equipment Management: Perform equipment set-ups and execute routine and preventative maintenance to ensure optimal function and reliability. Continuous Improvement: Proactively identify and implement improvements to processes, jigs, and methods that enhance product quality and overall efficiency (Lean/Six Sigma support). Quality & Compliance: Maintain accurate and complete documentation (batch records, logs, maintenance records) in strict compliance with GMP, ISO 13485, FDA, and MDR requirements. Project & Validation: Assist the Engineering team with process development, verification, and validation testing for both new and existing products. Teamwork & Training: Collaborate effectively with cross-functional teams (Engineering, Quality, R&D) during line validations and support product builder training on new work instructions. Essential Experience & Qualifications: Experience: 2-5 years of hands-on technical experience working specifically within the Medical Device or regulated Pharmaceutical/Cleanroom industry. Technical Knowledge: Proven experience operating and maintaining complex production equipment and supporting process improvement initiatives. Compliance: Working knowledge of QMS requirements, including ISO 13485, EU MDR, and FDA regulations. Skills: Demonstrated ability to read and interpret technical drawings, process diagrams, and equipment manuals. Key Attributes: Problem Solver: Excellent ability to troubleshoot and problem-solve quickly under pressure to minimize production downtime. Autonomous: Takes ownership of responsibilities and can work effectively in a team setting or autonomously as required. Detail-Oriented: Excellent documentation practices (GDP) and attention to detail. Aptitude: Passionate about manufacturing methodologies (Lean/Six Sigma) and continuous improvement. Next Step: If you are a hands-on technician looking for a pivotal role in a company with excellent career development potential, please apply in confidence today or contact James Cassidy for a confidential discussion.
