Were currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. 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 support within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection. Responsible for process ownership, demonstrating technical excellence as the subject matter expert for drug product processes Responsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events. Responsible for technology transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings. Provide on-site coverage in support of Commercial and / or Technology Transfer Person-In-Plant Activities. Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations and Quality Ensure that Site is inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory. Responsible for participation in creating, sharing, and adopting best practices and business process strategies. Education & Experience Requirements: Bachelors degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field. Minimum of 3 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance Proven expertise in aseptic operations, analytical testing, process development and tech transfer. Experience with lyophilized products advantageous Experience in start-up facility advantageous Experience in deviation management and/or change control and/or equipment support and/or equipment qualification, and/or project management. If interested in this posting please feel free to contact Sen McCarthy on or for further information.
Were currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Cork. 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: Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems. Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks. Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems. Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements. Execute/Participate in change controls and other compliance related tasks e.g. non-conformances. Support regulatory audits Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads. Support, lead or guide others in CQV projects. Education & Experience Requirements: Degree in a Science or Engineering discipline. Experience in a GMP environment essential. Minimum 5 years experience in a similar role. Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment. Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels If interested in this posting please feel free to contact Sen McCarthy on or for further information.
Manufacturing Engineer Medical Devices | Catheter-Based Technology A growing, innovative medical device company is seeking a Manufacturing Engineer to join its engineering team. This organisation is focused on developing advanced catheter-based technologies to improve outcomes for patients This role offers an excellent opportunity to work in a hands-on, multidisciplinary environment, contributing to both manufacturing process development and device design within a regulated medical device setting. The Role As a Manufacturing Engineer, you will support technology advancement projects, including the development of new manufacturing processes, device concepts, and the verification and validation of new technologies and methods. You will work across manufacturing and product development, supporting builds for testing, clinical studies, and commercial use. Key Responsibilities Conceive, develop, and improve manufacturing processes Plan, support, and manage device builds for testing, clinical, and commercial purposes Support verification and validation of new product designs and processes Prepare and maintain project plans, specifications, and development documentation Identify and liaise with suppliers and vendors for materials, processes, and equipment Support development of new methods of device manufacture Rapidly prototype product and fixture concepts using standard catheter-building techniques and tools such as 3D printing Perform mechanical modelling and analysis using SolidWorks or similar CAD software Contribute to intellectual property generation where appropriate Requirements Degree in Engineering or related discipline Minimum of 3 years experience in the medical device industry, ideally within a manufacturing environment Hands-on engineering mindset with strong practical problem-solving skills Experience working with medical device polymers (catheter experience advantageous) Familiarity with manufacturing process development and validation principles Proficiency with SolidWorks or equivalent mechanical CAD tools Strong verbal and written communication skills Ability to work effectively in a collaborative, team-oriented environment Commitment to continuous professional and technical development Why Apply? Opportunity to work on meaningful, life-changing medical technology Broad exposure across manufacturing and product development Collaborative and inclusive engineering culture Strong career development potential within a growing organisation For further information please contact James Cassidy or call in confidence
Were currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. 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 Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream. Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ. Coordinate technical deliverables within Drug Substance to support the successful product launch. Provide technical support to the operations teams during commercial manufacturing. Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented. Support Batch Disposition activities by providing SME technical support for comment resolution. Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance. Support continuous process and quality improvements through the deployment of Lean Six Sigma tools. Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos. In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization. Education & Experience Requirements: Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience. Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches. Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma Experience in a risk-based approach to manufacturing through use of tools such as FMEA If interested in this posting please feel free to contact Sen McCarthy on or for further information.
Senior Manufacturing Engineer Medical Devices | Catheter-Based Technologies A fast-growing, innovative medical device company is seeking a Senior Manufacturing Engineer to join its engineering team. This organisation is developing next-generation catheter-based technologies aimed at improving outcomes for patients This is a hands-on role within a multidisciplinary environment, offering the opportunity to influence both manufacturing process development and device design in a highly regulated, cutting-edge setting. The Role As a Senior Manufacturing Engineer, you will play a key role in advancing new technologies from concept through to validated manufacturing. You will contribute to the development of novel manufacturing methods, rapid prototyping, and the design and verification of catheter-based devices. Key Responsibilities Lead the development and optimisation of new manufacturing processes Rapidly prototype product and fixture concepts using standard catheter-building techniques and tools (including 3D printing) Perform mechanical modelling and analysis using SolidWorks or similar CAD software Design fixtures and tooling for proof-of-concept, verification, and validation activities Support device design, development, and scale-up activities Drive process development, verification, and validation in line with regulatory requirements Collaborate with cross-functional teams including R&D, Quality, and Operations Identify and manage external vendors for materials, processes, and equipment Prepare and maintain technical documentation, project plans, and specifications Contribute to intellectual property development where appropriate Requirements Degree in Engineering or related discipline Minimum of 6 years experience within the medical device industry Strong hands-on, practical engineering mindset Experience working with medical device polymers (catheter experience highly advantageous) Proven capability in process development, verification, and validation Proficiency in SolidWorks or equivalent mechanical CAD tools Experience with rapid prototyping and fixture design Excellent written and verbal communication skills Ability to work effectively in a collaborative, fast-paced team environment Commitment to continuous professional and technical development Why Apply? Opportunity to work on life-changing medical technology High-impact role within an innovative and growing organisation Exposure to full product lifecycle development Collaborative engineering culture with strong technical ownership For further information please contact James Cassidy or call in confidence
Job title: Project Manager R&D Location:Ballybrit, Galway Benefits:Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke. Job summary: I am recruiting for a Research & Development Project Manager to lead projects from early concept stage development right through to commercialization. The Research & Development Project Manager will drive cross functional engagement, budget management and critical path deliverables in addition to being part of a global R&D team in based Galway, Ireland. The area of project focus will be developing device concepts and treatments to solve unmet needs in neurovascular disease states. Key Responsibilities: As an R&D Project Manager you will responsible for managing neurovascular interventional device product development from concept through to commercialization. Provide technical leadership to a team of engineers and scientists and is responsible for coordinating the key technical activities of a multi-disciplinary team to ensure the successful completion of the project within planned timescales and budget. Technical Responsibilities Drive ownership of critical technical tasks in the execution of new product development projects. Liaise with key opinion leaders/physicians to develop a deep understanding of the disease state, gather user needs; and articulate throughout the team. Translate needs requirements into technical specifications. Provide leadership to the team in the development of test models for prototype performance evaluations, building and testing of prototypes, test data analysis and interpretation, component and finished device assembly drawings/specifications, product materials selection, and process development. Identify and manage key technical risks and appropriate mitigations throughout the product lifecycle. Identify and recommend optimal solution(s) for commercialization being mindful of COGs targets. Program Management Responsibilities Develop project goals, project plan and budget estimates. Identify critical project tasks, define project strategy, and set team priorities. Identify and manage key program risks and associated stakeholders. Manage direct team and across functions to deliver on performance, time and cost targets. Report progress across the organization and to senior leadership. Leverage and liaise with external resources to achieve project goals. Experience required: Honours degree in Mechanical or Biomedical Engineering or equivalent. Project management qualification preferred. Significant experience in the medical device industry with experience of technical project leadership, and prior device product development experience as a Senior R&D Engineer is required. Experience working with interventional catheter, delivery systems and vascular implants a distinct advantage. Prior project management experience preferred, especially in relation to project planning, budget management & financial acumen, use of project tracker tools etc. Does this sound like your next career move for 2026? To apply and For more info forward your application to the link provided or contact me on OR Benefits: Bonus, pension and healthcare
Job title: Director of Process Development Location: Limerick Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As a Process Development Director you will lead the design, optimization, and scale-up of manufacturing processes for biosynthetic, medical device products. This R&D role partners closely with Technical Operations, Supply Chain and Quality to ensure robust, scalable, and compliant processes from early development through to commercial production Role: Lead the end-to-end process development lifecycle for biosynthetic, medical device products, from concept through scale-up and commercial manufacturing transfer Define and execute the process development strategy, roadmaps, and risk management plans to ensure on-time, on-budget delivery with robust process performance Design, run, and analyze design of experiments (DOE) and other statistical methodologies to understand critical process parameters and their impact on quality and yield Develop scalable, robust manufacturing processes that meet quality, regulatory, and cost objectives; drive design for manufacturability and design-to-cost initiatives Plan and manage technology transfer activities from development to production lines, including support in process validation (IQ/OQ/PQ), commissioning, and start-up support Partner with Formulation, Technical Operations, Manufacturing, and Quality teams to select equipment, automation, and process technologies; evaluate capital project needs and contribute to / manage budget planning Experience required: Bachelors degree in Chemical Engineering or a closely related field with an advanced degree (MS/PhD) preferred 10+ years of experience in process development, process scale-up, and manufacturing transfer in medical devices or similarly regulated industries (e.g., pharma, biotech) with hands-on leadership responsibilities Deep knowledge of GMP/ISO 13485 quality systems, CAPA, change control, document control, and regulatory expectations for medical devices Proven expertise in process characterization, design of experiments (DOE), statistical analysis, and robust process validation (IQ/OQ/PQ) Strong background in one or more of the following process areas common to medical devices: polymer processing, lyophilization, polymer milling, coloration, and sterilization, with a bias toward reliable, scalable polymer manufacture Demonstrated success in technology transfer from development to manufacturing to meet commercial demand Excellent project management, planning, and budget management skills; ability to manage multiple programs concurrently Travel: occasional travel to sites, vendors, and customers as needed (typical expectation: light to moderate travel). Role is EU based, with a possible need to relocate to the manufacturing location with Collaborative mindset with the ability to build strong partnerships across R&D, Technical Operations, Quality, Regulatory, and Supply Chain Does this sound like your next career move for 2026? To apply and For more info forward your application to the link provided or contact me on OR Benefits: Bonus, pension, healthcare, care allowance
Job Title:Senior Electrical Engineer Location:Galway Benefits:Excellent salary, bonus, healthcare, pension, hybrid working. The Role: As a Senior Electrical Engineer, you will design, develop, and integrate complex electrical systems for my clients innovative Cardiac Ablation Solutions products. This role provides a unique opportunity to lead challenging projects, mentor team members, and contribute directly to life-changing technologies. You will work cross-functionally with teams in mechanical engineering, software development, quality assurance, and manufacturing to drive projects from concept through production. Your work will help my client achieve their mission of alleviating pain, restoring health, and extending life for millions of patients worldwide. The Cardiac Ablations Solutions Unit develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. Duties & Responsibilities: Perform system-level integration of hardware, firmware, and software components. Conduct risk assessments and root cause investigations for electrical issues, implementing robust corrective and preventive actions. Manage product changes and related change control activities, ensuring design documentation (e.g., BOMs, specifications, drawings) is updated and maintained accurately. Partner with reliability and manufacturing teams to optimise designs for scalability, cost efficiency, and high performance. Support verification and validation activities to ensure the safety, compliance, and efficacy of the product. Lead or contribute to the design, development, and testing of electrical systems and circuits for medical devices, ensuring compliance with applicable regulatory standards (e.g., IEC 60601). Investigate and analyse field-returned products, conducting engineering analyses and testing to determine root causes of failures. Develop detailed specifications, schematics, and PCB layouts, collaborating closely with cross-functional teams to meet design and performance requirements. Design, develop, and qualify functional and safety test systems at both the product and PCB levels. Support and potentially own CAPA (Corrective and Preventive Actions) processes and manage issue escalations to resolution. Provide troubleshooting and problem-solving support to manufacturing teams and key suppliers, aiming to increase yields, maintain process capabilities, and improve cost-efficiency. Mentor and coach junior engineers, fostering a collaborative, innovative, and high-performing engineering environment. Stay current with advancements in electrical engineering, emerging technologies, and industry best practices. Education & Experience Required : Bachelors degree in engineering required with a minimum of 4 years of electrical design experience or advanced degree with a minimum of 2 years electrical design experience. Experience in medical device or highly regulated industries. Experience with analog, high voltage or RF circuit design. Experience with system-level integration of hardware and firmware. Experience in developing hardware test systems for design verification or production testing. Solid understanding of EMC design and test principles per IEC 60601. Demonstrated skills in writing engineering documents (specifications, test plans, etc.) Knowledge of Design for Manufacturing and Test (DFM & DFT) principles. Knowledge of Six Sigma, Lean, or other problem-solving methodologies. Strong verbal and written communication skills. Team-oriented mindset with a collaborative work ethic. Hands-on experience with prototyping, testing, and debugging PCB assemblies. Experience with analysis, simulation, and CAD tools for PCB design (e.g., Minitab, MATLAB, SPICE, Altium, Cadence) 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: Healthcare, Annual Bonus,Pension,Hybrid
Contract Development & Manufacturing Manager (hybrid) RK4894 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: Laboratory Supplier relationship management, including development and reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers. Building and maintaining strong partnerships with all external laboratory functions to increase overall effectiveness and success of programs. Ability to operate in highly matrixed teams. Project management of a portfolio of cross-disciplinary external projects traversing the areas of Drug Product, Drug Substance, and Attribute Sciences. Primary focus will be to manage delivery of analytical work packages (method qualification, method transfer, release testing, stability testing, characterization sample management ) with external contract laboratories Actively participate in cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Amgen's Contract Testing Laboratory sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent. Responsible to ensure analytical escalations are captured and communicated accurately and timely Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects Ensure that designated ACDM lead programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development. Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects Supplier evaluation and selection This position will require occasional domestic and international travel Educational and Experience Bachelors or Masters degree in Science, Engineering, Biotechnology, or related discipline. 5 years experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing. Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results Experience interfacing with domestic and international CTL /CRO organizations Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Quality Assurance Specialist (hybrid) RK4868 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: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory expectations. Quality review and approval of Process Development and Validation documentation - Technical transfer documents - Validation Protocols, executed validation documents and reports 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. Science or Engineering related discipline preferred. Understanding of principles of Validation and New Product Introduction Experience in aseptic manufacturing Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing) If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
