3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Life Science Recruitment Managing Consultant at LifeScience Recruitment Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. Role: Principal Device Equipment Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Principal Device Equipment Engineer will be an SME in the management and delivery of equipment, inclusive of specification, procurement, delivery, qualification, and project management of the same. The successful candidate will lead equipment delivery projects with the suppliers, inclusive of budget management, and ownership for specification through to qualification. The candidate will work in collaboration with cross organisational teams. This is a Global role that is key to the success of GDD’s varied product portfolio delivery and will provide the successful candidate exposure to all aspects of combination device design, development, and production. Day to day: Develop engineering systems strategy for program delivery. Pilot to scale up, subassembly, final assembly, labelling, packaging, transport, and auxiliary systems. Establishing and maintaining timelines against organization requirements and identify external partners/OEMs to meet internal needs. Lead for engineering systems in cross departmental teams. Manage engineering system objectives in line with program delivery. Supporting the device program team through communication, plan management, technical review and execution, budgetary management, risk assessment, etc. Experience required: Degree in Science/Engineering with 7+ years’ experience in pharmaceutical and/or medical device development or similar role. Strong project management experience is highly preferred. Enthusiastic, conscientious, highly driven and motivated person. Good communication skills and commitment to teamwork are essential. Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie Seniority level Mid-Senior level Employment type Full-time Job function Manufacturing Industries: Medical Practices, Medical Equipment Manufacturing, and Biotechnology Research #J-18808-Ljbffr
Manufacturing Engineer – Enniscorthy This is an exciting opportunity to join the world's most renowned medical device company on a 12 month fixed term contract, with the potential of a permanent role in the future for the right candidate! The Manufacturing Engineer is involved with ensuring all manufacturing processes are run safely and to schedule. You will report to the Engineering Manager or Engineering Lead. My Client: My client designs, develops and manufactures innovative and exciting minimally invasive medical devices associated with peripheral artery disease, diabetes, surgical procedures, and oncology. Their teams bring to the market great novel solutions, as well as keep developing internal equipment allowing us to be flexible. Responsibilities: Participate and lead on project teams with engineers, technicians and other professionals of various disciplines/departments to continuously improve product, equipment, and fixture processes on the manufacturing line. Initiate and develop process validations, software validation and equipment validations. Equipment design, development and optimization for more complex equipment. Perform engineering work typically including one of the following: process/product improvements, test of materials, preparation of specifications, process study, evaluation of process models/process improvements, development improvement of equipment, tools, fixtures and report preparation. Understand and perform Project plans, risk analysis project updates and Project implementation for more complex projects. Understand and can create Process FMEA (Failure Mode Effects Analysis) review and update. Education: You will have a minimum of Bachelor’s degree in engineering plus a minimum of two years’ experience (ideally in the medical device) or a Master’s degree in a technical field. Any GMP experience is a distinct advantage. Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role. Contact: Colin Clare on 0870608656 or colin.clare@lifescience.ie for more details. #J-18808-Ljbffr
A Senior Manager Device Supplier Assurance is required to join a leading global life science business in Dublin. This is a critical Supplier Quality role where you would conduct supplier audits, generate and manage Supplier Control SOPs and generate Quality Technical Agreements and contractual agreements for CMO’s and service providers. The Role Primary contact for communications, escalation and resolution of supplier related quality and technical issues that may impact program timelines or contractual obligations. Conduct supplier technical assessments identified as technical capability for potential business opportunities. Maintain a supplier technical assessment schedule and approved supplier list against business needs. Support the generation of projects, purchasing/supplier specifications. Manage & execute supplier related change controls and supplier complaints. The Person Degree in Engineering/Biomedical Science, Engineering or equivalent. A qualified Supplier Auditor with strong supplier audit experience. Proven experience within a medical device supplier lead role. Experience within a medical devices and container closure systems environment with emphasis on drug delivery technologies would be a distinct advantage. Experience of supplier evaluation & selection against technical need. Excellent technical report writing skills. Willingness to travel (Around 20%). For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie Seniority level Mid-Senior level Employment type Full-time Job function Supply Chain and Quality Assurance Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing #J-18808-Ljbffr
A Lead SAP Analyst - Logistics & Supply Chain is required to join a leading global Biopharmaceutical business based in Limerick. This is a fantastic opportunity to join a global business focused on developing and manufacturing breakthrough medicines. This is a site-based role on a brand new technically advanced manufacturing site. The role will support the business processes and systems for the manufacturing site inbound, internal, and outbound logistic flows. The role will provide analyst support for an integrated set of systems that includes SAP S/4HANA and SAP Extended Warehouse Management (eWM). The Role Understand the S4 Hana and EWM systems and equipment involved in logistics operations and material control including the associated data and data flows. Provide support to the Site Supply Chain and Logistics teams on how to resolve business user requests and issues. Understand how the logistics systems and processes integrate with other critical systems like MES (Manufacturing Execution System) and Process Automation e.g. ASRS (Automatic Storage and Retrieval System). Build expertise in the SAP eWM technology and its integration to additional SAP Supply Chain modules. The Person Bachelor’s Degree in Information Technology, Computer Science, Engineering or related field (Level 8 or equivalent). 8+ years of experience in pharmaceutical manufacturing. Experience with integrated logistic flow in a manufacturing facility, including prior experience with SAP or equivalent ERP systems. Knowledge of System Development Life Cycle. cGMP Experience Seniority level Associate Employment type Full-time Job function Supply Chain and Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
We’re currently recruiting for an exciting opportunity 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. Duties Oversee both internal and external engineering, calibration and maintenance teams to ensure all equipment is functioning optimally. Respond quickly to equipment failures, diagnosing issues and implementing solutions to minimize downtime. Ensure the reliability and uptime of manufacturing equipment, with a particular focus on multiple filling lines. Conduct training sessions for maintenance staff, emphasizing best practices in equipment handling, maintenance, and safety. Develop and monitor Key Performance Indicators (KPIs) for equipment uptime and maintenance efficiency. Lead investigations into equipment-related deviations, managing Corrective and Preventive Actions (CAPAs), and overseeing Change Controls to ensure compliance with regulatory standards. Education & Experience Experience in a manufacturing environment within the pharmaceutical industry, with a focus on engineering and equipment reliability. Fluent in English, with strong communication skills to effectively collaborate with teams and report on maintenance and engineering activities. Ability to work in a hybrid model, committing to 3 days on-site to oversee operations directly. Demonstrated experience in reducing downtime, increasing throughput, and ensuring compliance through effective engineering and maintenance practices. If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information. #J-18808-Ljbffr
Senior Electronic Design Engineer Our client, a high potential medical device startup, is currently seeking a Senior Electronic Design Engineer to join their team. Reporting to the R&D Director, the Senior Electronic Design Engineer will be required to support hardware development of a novel device. Role/Responsibilities: Design and develop complex electronic and mechatronic hardware systems for high-volume medical devices and related test setups, involving both analogue and digital electronics, with a focus on embedded system design and implementation. Be involved in all steps of the development cycle with a focus on early design through manufacturing and testing of products and product prototypes. Design, plan, set up, conduct, document, and review development tests. Keep up to date with the latest developments in the field to ensure the company remains at the forefront of innovation. Skills/Experience: BS or MS in electrical or computer engineering or related training background. 5+ years’ experience in embedded hardware development, as well as the testing of controllers. Experience in SPICE Simulation and PCB Design is beneficial. Strong record in rapid electronics prototyping, debugging, and failure analysis, as well as working with lab procedures and equipment. Experience with PCBs, grounding, shielding, and EMC/EMI design, filtering techniques including analogue, digital, and embedded processing circuitry is beneficial. Relevant experience in the electronic or medical device industry and experience with electrical hardware development in compliance with regulatory requirements (e.g., IEC 60601 3rd ed., IEC 61000) is a plus. Theoretical engineering knowledge in signal theory, analogue and digital electronics, high frequency electronics, mathematics, and electronic manufacturing techniques. Strong work ethics and a team-oriented mindset. Startup experience is a plus. For further information please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence at 086 0204322. #J-18808-Ljbffr
QUALITY & REGULATORY MANAGER Our client, an indigenous Irish medical device company who has recently undergone significant investment, is currently seeking a Quality and Regulatory Manager to join their team. Reporting to executive leadership, the Quality and Regulatory Manager will have a proven ability to lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, demonstrate excellent people and team management skills, and experience of quality management in the context of R&D and design control. This is an exciting opportunity to join a company with huge growth plans. Role/Responsibilities To lead the company-wide quality assurance agenda, ensuring that we meet customer requirements for products and services as well as regulatory compliance in target markets. Ensure the effective functioning of continuous quality improvement based on performance measurement. Ensure there is adequate control of design activity to ensure product quality. Lead and manage all areas of Risk management as it relates to design control in accordance with ISO14971. Responsible for the ongoing maintenance, audit, and continuous improvement of the Quality Management System, to ensure compliance to relevant standards for Europe, UK, North America, and Asia Pacific. Responsible for regulatory clearance and regulatory maintenance for the Company’s products in target markets. Responsible for the implementation of the Home healthcare and electrical safety standards. Management of the QA team. Proactive management of the processes to ensure product and service quality. Act as Management Representative for the Quality Management System. Manage the maintenance of the Quality System to ISO13485, and FDA requirements. Responsible for FDA facility inspections, notified body audits, and other audits and inspections as required. Establish infrastructure to assure quality and work with relevant teams to ensure performance improvement. Ensure the effective functioning of design controls to ensure product quality. Represent the quality department in all NPI/NPD activities to ensure that all new products are compliant with appropriate international quality and regulatory requirements. Complaints handling for medical reporting and filing to the appropriate competent authorities. Regularly review and manage change control process to ensure it remains effective and efficient. Ensure products are cleared to the appropriate markets as per Regulatory plan. Manage Regulatory Affairs support to internal and external customers. Ensure the company is kept informed of and give direction on changing regulatory and compliance requirements e.g. REACH, ROHS2, etc. Manage the Quality team to ensure the proactive delivery of departmental objectives and empower the team to actively support and assist other departments in complying with quality requirements. Data collection and analysis for monthly meetings and management review. Skills/Experience University Degree or a Post Graduate qualification, preferably in Quality Assurance. 8+ years of experience in Medical Devices or other similar regulated industry. Significant regulatory affairs experience including experience of international regulatory processes. Knowledge of product certification testing requirements for Medical Devices. In-depth knowledge of maintaining a certified Quality Management System. Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc. Previous experience of the impact of regulatory control on commercial products. Trained QMS Internal Auditor. Awareness of quality assurance processes. High level of attention to detail. Proven leadership skills. Excellent verbal and written communication skills. Results-oriented and a self-starter with the ability to work on own initiative. Knowledge of and commitment to continuous improvement and problem solving. Promote best practice and knowledge of the QSR and ISO standards. Advanced Microsoft Office and reporting tool skills. Strong project management skills. For further information please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence 086 0204322. #J-18808-Ljbffr
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical 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. Duties Ensure the highest Quality, Compliance and Safety standards primarily with equipment qualification, commissioning and validation, project management but relating to all activities. Work within a team to enable the team’s performance within the Technology Transfer group and Tech Ops. Responsible for the qualification of new equipment to support vaccine manufacturing, providing technical support to the team and leading projects/project management. Development and execution of protocols to support equipment qualification. Technical Review, ownership of and impact assessment of Global Change management records as required. Recommend technical approaches in line with global and local standards. Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances. Contribute for driving a culture of Continuous Improvement by deploying MPS within Tech Ops on projects such as: problem solving, reducing cycle time, Lean principles within the new processes. 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. Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Lead Knowledge Management efforts within the team. Education & Experience Process engineering experience in biopharmaceutical/vaccines environment would be an advantage. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology). Prior experience with equipment commissioning, qualification, and validation. If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information. #J-18808-Ljbffr
We’re currently recruiting for an exciting opportunity with a 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. Duties Execute cleaning cycle development and PQ of equipment. Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports. Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments. Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards. Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT. Technical report writing, statistical analysis of data. Adherence to the latest regulatory guidelines. Represent the IPT on cross-functional project teams. Provide technical input and support and present as an SME on relevant topics during regulatory inspections. Adherence to highest standards for Compliance (Quality and Safety). Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations. Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Education & Experience Experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field. Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering. A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records. If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information. #J-18808-Ljbffr
Sourcing Specialist CK/AFUT-170505 Criteria Required: Technical Background (e.g. chemistry degree or equivalent) Excellent Communication Skills IT Literate Overall Objectives: Development of Customer Relations Development of Supplier Relations Familiarisation with Principals products Familiarisation of best International Supply options Day-to-Day Tasks: Speedy response to customer's enquiries 'Current Time' completion of Enquiry Forms Compilation and maintenance of Enquiry Log Reconciliation of Customer's quality needs (specification reconciliation and creation) Requesting with discernment best offers from prospective suppliers Provision of import duty information Obtaining duty 'BTIs' Provision of 'EINECS' and other transport regulation status Calculation of quotation proposal for discussion with Sales Managers Quoting Customers (when appropriate) Getting Orders! Ensuring conformance to ISO procedures Interaction and information provision for Logistics department Completion of Customer Questionnaires Updating of Supply Agreement Contracts Database Handling Complaints in tandem with Logistics where required Sample handling ISO Inspection Irregular Tasks: Compilation of Information for Principal's reports Attendance at relevant exhibitions Visits to Principals and other Suppliers Customer visits (usually with Sales Managers) Attendance at supplier quality audits Provision of department resources required for budget Suggestions for ISO and SOP improvements Marketing Research for Sales Departments Contribution to and support of Marketing Projects Assisting with document creation for 'Project' Enquiries Participation in ISO Audit Familiarisation and maintenance of Sourcing Library Rotational attendance at LWP meetings Any candidate applying must hold an EU Passport and be willing to work on-site in Tipperary 5 days per week. Reach out to carla.kemp@lifescience.ie or ring 087 721 7933. #J-18808-Ljbffr
