Role: Senior Quality Systems Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary, hybrid working, bonus, pension and healthcare Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance of the company’s Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway. Responsibilities: Ensure the Veryan Quality Systems are compliant with, the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169. Maintenance and continuous improvement of the quality management systems. Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines. Review & approval of Non-conformance, CAPA and Complaint investigation reports. Act as Coordinator for the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required. Track audit actions from initiation to closure. Coordinate activities in the preparation and management of audits by regulatory bodies. Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc. Prepare and present data to management on quality system performance, including Monthly Quality Reports. Generate Quality Systems data as required for Post Market Surveillance purposes. Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements. Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required. Role: Senior Quality Systems Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary, hybrid working, bonus, pension and healthcare Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance of the company’s Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway. Responsibilities: Ensure the Veryan Quality Systems are compliant with, the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169. Maintenance and continuous improvement of the quality management systems. Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines. Review & approval of Non-conformance, CAPA and Complaint investigation reports. Act as Coordinator for the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required. Track audit actions from initiation to closure. Coordinate activities in the preparation and management of audits by regulatory bodies. Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc. Prepare and present data to management on quality system performance, including Monthly Quality Reports. Generate Quality Systems data as required for Post Market Surveillance purposes. Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements. Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required. Education & Training Educated at a minimum to a Diploma Level in an Engineering, Science, or Quality Assurance discipline. Training/Qualification in Quality Systems, Complaints and CAPA is highly desirable. A minimum of five years’ relevent experience in the medical device industry. Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required. Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable. To apply for more info call me on 087 0612325 or email Thomas.gallagher@lifescience.ie #J-18808-Ljbffr
A growing Medical Device company in Galway is seeking a Graduate R&D Engineer to play a key role in their R&D projects and team. This position offers a hybrid working model and the chance to work with innovative technology. Candidates should hold a Bachelor’s or Master's degree in Engineering. The role comes with a competitive salary, bonus, and benefits including a pension scheme, private medical insurance, and opportunities for further training and development. #J-18808-Ljbffr
Commercial Attribute Science Snr Associate 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. This role will be responsible for Forensics & Defects activities involving forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products. Duties: Leads / assists forensic investigation and identification of defects arising from drug product manufacture at ADL and write up of these investigations to cGMP standards. Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterization of automated / semi-automated / manual finished drug product visual inspection equipment at ADL. Act as support for the Attribute Sciences function on cross functional teams/programs. Timely documentation of Analytical data in the electronic notebook system. Understanding of data flow in laboratory systems and data integrity. Participate in the peer review of analytical data. Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory. Ensure the laboratory is operated in a safe and environmentally friendly manner. Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system. Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables. Ensure timely completion of Laboratory Investigations, Deviations, PMAFs. Participate in internal/external audits/inspections as required. Plan and implement procedures and systems to maximise operating efficiency. Manage and contribute to the achievements of department productivity and goals. Engage with the Continuous Improvement Process and MyGreenLab® philosophy. Education and Experience: 3-6 years of experience in the Pharmaceutical Industry with a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline. Experience with Regulatory inspections and interaction with inspectors is preferable. Experience with developing, validating, troubleshooting, analytical methods. Understanding of the Change Control and Variation Management Process. If interested in this posting please feel free to contact Avishek Singh at Avishek.singh@lifescience.ie or 0872827991 for further information. #J-18808-Ljbffr
A leading medical device manufacturer in Connacht is seeking a Supply Chain Specialist. This key role focuses on MRP execution, supplier coordination, and logistics management to ensure materials meet demand. The ideal candidate will have a degree in Supply Chain or Procurement, with 2–3 years experience in MedTech or pharmaceuticals. Strong analytical and organisational skills are required. This position offers exposure to cross-functional operations in a fast-paced environment. #J-18808-Ljbffr
Role Quality Engineer – Hybrid Role Location Enniscorthy, Wexford Company My client are one of the largest global medical technology companies in the world and are advancing the world of health by improving medical discovery, diagnostics and the delivery of care. They have over 75,000 employees and a presence in virtually every country around the world! Role Overview This role is a 18 month fixed term position. It offers hybrid working (3 days in the office and 2 from home) with a competitive salary and package. Reporting to the Senior Quality Engineer, this individual will be a key member of the Supplier Quality team. Key Responsibilities and Advantages Lead/participate in continuous improvement/CAPA team activities Perform risk management activities in a cross-functional environment Ensure regulatory compliance in area of responsibility to cGMP’s, with the ability to train others Ensure that documentation and work practices comply with ISO and regulatory requirements Develop, maintain, and improve the quality management system Assess quality management system effectiveness through internal audit and performance review Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines Required Qualifications Third level technical / Science qualification plus Min 2 years in the medical device or pharmaceutical industry, preferably within supplier management Knowledge of quality management systems ISO 13485, GMP To apply or for more info call me on 0870608656 or emailcolin.clare@lifescience.ie #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. Our client is seeking an experienced System Owner Engineer (SOE) to lead the implementation and operational readiness of syringe filling equipment and associated single-use systems as part of a major site expansion in Dublin. This is a critical role supporting a high-speed, GMP-regulated fill-finish manufacturing environment. Key Responsibilities: Leads / assists forensic investigation and identification of defects arising from drug product manufactured and write up of these investigations to cGMP standards. Act as System Owner (SO) for syringe filling equipment from design through to PQ and commercial operation. SO during equipment implementation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation activities. Drive manufacturing readiness, start-up, and handover to operations. Ensure compliance with GMP, regulatory, and copany’s global standards. Develop and implement: Maintenance strategies Critical spare parts strategy Preventive maintenance programs Lifecycle asset management plans Provide technical leadership during deviation investigations, troubleshooting, and performance optimisation. Partner cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering. Support new product introduction and technology transfer activities. Qualifications and experience: Bachelor’s Degree in Mechanical, Electrical, Chemical, or related Engineering discipline. 5+ years’ experience in biopharmaceutical manufacturing engineering. Proven experience in aseptic syringe filling systems (high-speed lines preferred). Strong knowledge of: GMP and regulatory expectations, Annex 1, Aseptic processing principles, Equipment validation lifecycle Experience with single-use technologies in fill-finish environments desirable. Demonstrated ability to lead complex equipment projects from design through operational readiness. Strong troubleshooting and root cause analysis capability. If interested in this posting please feel free to contact Avishek Singh at avishek.singh@lifescience.ie for further information. #J-18808-Ljbffr
Key Account Manager (Retail & Pharmacy National Accounts) Key Account Manager – (Retail & Pharmacy National Accounts) Our client is a leading provider of Eyecare and Healthcare products across Ireland, UK and US. They are currently seeking a Key Account Manager to join a strong team and will report into the National Account Manager in the UK. The person can be remote based in Ireland - HQ is in Dublin. This role ensures that interaction with our clients Key Accounts in both the Pharmacy and Health & Beauty channels is collaborative in nature and grows their lifetime value against both revenue, distribution, market share and profitability targets. This will be accomplished by understanding and anticipating the current and future business needs of the key accounts, communicating these across the organisation and presenting technical and business solutions to meet those needs. You will be working with the National Account Manager on Pharmacy accounts such as Well, Asda, Opticians and Pharmacy & other regional pharmacy chains. You will also support the NAM with developing our clients Allergy business within the Health Food Stores channel. Open to candidates from the Ireland only. Role/Responsibilities Developing trusted relationships with a portfolio of key customers, by understanding their needs and delivering solutions that drive their & our business forward Expanding and networking relationships within these customers by continuously proposing solutions that meet their objectives Devising strategies, recommendations, and briefing documents for working with these key accounts. Understand the key drivers behind our business with the key accounts; be able to identify and examine issues with KPIs and bring these to the attention of the national account team or the appropriate internal team Work with the Marketing Product Managers to compile specific marketing collateral as required by account Flexible attitude to working at all levels with the account panel you have responsibility for, from training key account staff to help them understand, promote, and sell our clients products through to top-to-top meetings in your regional optical accounts. Be inquisitive about how the key accounts operate; work at identifying any needs outside of our clients current product offering and flag these with team management and other relevant internal departments. Act as a strong customer advocate within our business to ensure that all internal stakeholders understand the key challenges & opportunities in the Optical channel Ability to build strong internal relationships to ensure that you have the support required to deliver against your targeted accounts. Serve as the link of communication between key customers and internal stakeholders Work with Supply chain and customer services to ensure the correct products and services are delivered to customers in a timely manner Liaise with Quality and Regulatory to address any issues as required Understanding structural and policy changes at our key accounts Attention to detail is a must with an ability to summarise and communicate the outputs of complex and lengthy documents Flexible attitude to working hours and willingness to travel across Ireland and UK to meet with customers face to face, along with store visits to keep updated on fixtures and promotions. Qualifications / Experience Business or Science related third level qualification essential Full, clean Irish Drivers licence essential 2 to 3 years minimum customer facing experience in a territory or key account role. Experience in account management within one or more of the Pharmacy, Health & Beauty or Health Foods stores channels is desirable, specific experience with customers like Boots, McCabes, CarePlus etc or Grocery customers like Tesco, Dunnes Stores, SuperValu, Centra, ALDI, LIDL etc and regional chains would be preferable. Ability to take on challenging product knowledge Ability to prepare and present with influence on all levels within external customers and with internal stakeholders as well. Ability to influence and lead others without direct-line management responsibility Energy, resilience, and enthusiasm is a key advantage in this role Customer focused (both external and internal) Ability to work well on one’s own initiative and as part of a cross functional team Communication and interpersonal skills - comfortable and capable of communicating with all levels within and outside the business both written and verbal with a high level of professionalism. High attention to detail Organisational skills - self-motivated and able to demonstrate strong organisation and prioritisation skills in a sales and relationship management environment. Personal Effectiveness - must be able to work under pressure and autonomously; successfully manage a very diverse and demanding workload. Strong technical and computer literacy; skilled in the use of tools such as Word, PowerPoint, Outlook and Excel. For further details please contact Karen Shiel on 087 745 2487 or send CV to karen.shiel@lifescience.ie #J-18808-Ljbffr
A leading pharmaceutical firm in Dublin is seeking a Senior Manufacturing Specialist to provide technical support for the External Supply manufacturing team. The ideal candidate will have 5 years of experience in GMP environments and a Bachelor’s Degree in a relevant field. Responsibilities include managing quality records, liaising with CDMOs, and facilitating cross-functional teams. This role offers the opportunity to join a multinational recognized for excellence in its field. #J-18808-Ljbffr
A leading Pharmaceutical organization in Cork is seeking a Senior Manufacturing Process Specialist for a 12-month contract. The ideal candidate will provide technical support to ensure efficient manufacturing while maintaining compliance with GMP and EHS standards. With over 5 years of experience in an Aseptic/Sterile or API manufacturing role, the candidate should possess strong communication and organizational skills. This position offers an opportunity to work in a dynamic environment focused on continuous improvement. #J-18808-Ljbffr
Overview CQV Engineer — Onsite — RK5228 — Contract 12 months — Dublin 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. Key Responsibilities Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process from initial design through qualification to validation maintenance (e.g. Periodic review). Coordinate the qualification activities and maintain equipment and utility systems in a validated state. Develop or qualification approaches and equipment family strategies. Assist in the development of User Requirement Specifications (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES). Develop and approve C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQs, PQs etc. for the vial and syringe filling, formulation, inspection and utility areas in line with GMPs, regulatory requirements and corporate standards. Ensure Startup of equipment/utilities is completed in a safe and coordinated manner and ensure the safe startup of equipment and utilities. Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed. Support NPI introductions to equipment. Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance with all necessary regulations. Participate in regulatory inspections, regulatory filings and RTQs (response to questions). Update and maintain Standard Operating Procedures (SOPs) in accordance with site and corporate requirements. Take ownership for quality compliance in all activities you are responsible for, ensuring approaches are aligned with current guidelines (ICH/ASTM). Ensure the site change control procedure is adhered to. Education and Experience 6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management. Technical qualification at third level or equivalent in Engineering or science. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects. Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience of sterile / biotech equipment within the pharmaceutical industry is preferred. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. #J-18808-Ljbffr
