Senior Manufacturing Process Specialist RK5097 Contract 12 months Cork Were 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. As a core member of the business unit the Manufacturing Process Specialist is responsible for providing technical support to the business unit in ensuring efficient manufacturing while ensuring compliance with GMP, EHS standards at all times. Duties: Development of new and revised manufacturing and cleaning recipes in line with Master Batch book requirements. Development of and subsequent reporting on metrics relating the overall end to end performance of the business unit including the preparation of scorecards, dashboard and data for management review. Management of investigations (including customer complaints, EHS incidents, NCPs etc.) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions. Management of the manufacturing related aspects of the Change Control system in line with site procedures. To participate in HAZOP studies so that potential problems are identified and designed out of processes. Identification of opportunities for improvement within the manufacturing process through trend analysis and continuous review of all operations (e.g. completion of Self Inspections/ Internal Audits/process Optimization). Partnering with business unit personnel in the proactive identification of innovative solutions to problems. Develop re processing /rework strategies, test methods and protocols. Attendance at operations meetings as required in support of the Business Units. Experience and Education: Third level Degree in a science or pharmaceutical discipline. 5 years experience in a manufacturing operations role within an Aseptic/Sterile or API or biological/ pharmaceutical industry. Strong communicator, organisational skills, adhering to deadlines LEAN experience/qualification would be advantageous If interested in this posting please feel free to contact Rachel Kent at Life Science Recrutiment for further information.
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. This person will have previous relevant experience of Pretreatment Systems, Clean Steam, WFI and Process Air generation and distribution systems, to provide client side design input at Detailed Design, Commissioning, Qualification and handover stages of a design project for a Fill/Finish Building. The scope of the role also includes design input and support during the project phases for various ancillary areas such as the existing Warehouse, a new -30Deg Coldroom, Laboratory reconfigurations and general site infrastructure, which are all collectively managed as part of the expansion project. Due to the nature of the role, the Clean Utilities Engineer will also be required to support FATs at vendor sites at times during the project. Duties: To support companys client side design team in its efforts associated with the new expansion. To provide technical expertise working with other project stakeholders, in order to achieve design deliverables To track, manage and communicate adherence to discipline project milestones To coordinate client side clean utilities (Clean Steam / WFI / CA) design by liaising with Site SMEs and companys Engineering Technical Authority (ETA) To assist client side design reviews in the area of Clean Utilities for the expansion project. To participate in cross functional package, area, or overall design teams as required in support of companys overall design goals and expectations. To input into Technical Assessment in support of the instrumentation framework, and/or procurement agreements. To participate in design reviews, model reviews, etc., and to input on technical elements of the design To execute Drawing, URS, HDS, SDS, Equipment & Instrument Specifications and other reviews associated with the company Clean Utility installations. To participate in CMSATs / Loop checking, including any trouble shooting activities To provide input and assistance to Automation, C&Q and Validation in terms of equipment packages as required. To participate in the design reviews and specifications review of any Vendor Package Equipment in the new Facility. Provide attendance / assistance for FATs / SAT / C&Q and Validation activities at various locations, site or Vendor, as required. To provide input into the calibration program for clean utilities. To coordinate with companys site Metrology Group to ascertain calibration requirements and to ensure the execution of calibrations, both equipment and field instruments, in line with these requirements. To liaise with the site Maintenance Group and to ensure that any data gathering required to support the MAXIMO system requirements. Education and Experience: Minimum of 5 years of experience in pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design. Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent. Direct experience in a similar scale project. Ability to challenge, defend and present technical aspects of design and commissioning. If interested in this posting please feel free to contact Avishek Singh at Avishek.sing for further information.
Clinical Safety Specialist Our client, medical device organisation, are currently recruiting for a Clinical Safety Specialist to support activities related to global clinical trials. This role ensures all aspects of safety are conducted according to procedure and in a compliant manner. This is a hybrid role based out of Dublin. Responsibilities Review, evaluate, and track incoming adverse events (AEs) including follow-up of ongoing events Collaborate with sites, monitors, and Contract Research Organizations (CROs) to ensure complete AE information is available for review Prepare event narratives to facilitate adjudication and reporting Act as liaison for clinical sites and cross-functional teams on safety monitoring Verify consistency and compliance in the application of protocol definitions for adjudication outcomes Provide input to the development and management of study documents (protocols, case report forms, monitoring plans, manuals, and other tools) Prepare safety reporting for annual reports, clinical study reports, investigator brochure updates, and other regulatory documents Develop and maintain study-specific Safety Management Plans, including event narrative and adjudication templates Assist in training study personnel on AE definitions per protocol Support the management of Clinical Events Committees and Data Safety Monitoring Boards Maintain the electronic database and clinical data structure for accurate, up-to-date information Communicate study status and timelines; escalate unresolved issues appropriately Maintain knowledge of FDA, ISO, competent authority, IRB/REB, and EC regulatory rules affecting AE reporting Support trial/regional enrollment strategy and execution Manage essential documents and Trial Master File, ensuring inspection readiness and continuous improvement activities Requirements Degree or masters degree in science, engineering, or related disciplines Minimum 2+ years experience in clinical safety or combined clinical safety/post-market vigilance, clinical research experience preferred Experience in cardiovascular disease preferred Experience with Class III medical device clinical studies preferred Expertise with medical device regulations and compliance guidelines (ISO 14155, 21 CFR 812, EU MDR, and other relevant guidance) Understanding and frequent application of quality principles for medical devices, ideally Class III implantables. Knowledge of Good Clinical Practice and regulatory standards Excellent communication, organizational, and time-management skills Supports data-driven decision-making and high-quality device development Demonstrates strong organizational and task management skills Ability to prioritize work, reach objectives, and challenge team decisions when appropriate Works effectively with others to achieve company goals Effective verbal and written technical communication, including presentations. Ability to travel For more information, please contact Sinéad Cullen on or
Job title: Quality Engineer II Location:Galway Business Park, Dangan Benefits:Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. Overview: This position requires experienced and proven track record in Quality Assurance and Quality & Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial. Development and supporting Quality Management System (QMS) activities, batch release, internal audits, and supplier management Responsibilities: - Responsible for compliance with policies and Procedures and applicable National and International Regulations. - Leads compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training). - Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. - Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required. - Provide expertise in the areas of quality assurance, controls and systems to support and develop the companies QMS. - Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements. - Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics. - Provide ongoing support to the internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial. - Gather and analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations and internal requirements Requirements: - Bachelor's degree in engineering or a related technical field. - Minimum of 2 years of experience in Quality engineering within the medical device industry, preferably with neuro interventional devices. - Strong understanding of basic engineering principles 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 Skills: Quality Assurance Systems Benefits: Bonus
Senior Contract Development & Manufacturing Associate Remote 80% Onsite 20% RK8225 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. The Sr Associate Contract Development & Manufacturing provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality Key Responsibilities: The successful candidate is expected to own and execute various quality record types, including Deviations (Major/Minor), CAPA, SICAR, Change Control and perform metrics oversight responsibilities. Liaise with Third Party CDMOs to maintain and monitor systems to ensure all record received are appropriately investigated and concluded per quality standards and procedures. Support/Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools. Optimise deviation management, corrective and preventive actions effectiveness to prevent reoccurring events. Report Third Party CDMO site performance metrics to site lead; identify improvement opportunities for site performance. Coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT) Oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team Facilitation of cross-functional teams (internal and external to External Supply). Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions. Participate in the assessment or implementation of continuous improvement projects or initiatives. Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting. Education and Experience: Bachelors Degree (L8) in Business Administration, Engineering or Science-related field 5 years of experience in GMP protein, API, DS, DP or packaging manufacturing environment Experience in roles requiring knowledge of cGMP principles, FDA and other regulatory agency guidelines, and validation principles Understanding of applicable manufacturing/testing processes (i.e. protein, API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Experience with supporting/managing Third Party CDMO sites Demonstrated experience with QMS & Digital tools including Veeva Vault, TrackWise, AI software. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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. Under minimal supervision, this role will be responsible for one or more of the following activities in QC including sample and data management and equipment maintenance. Duties: Liaise with site Planning, Manufacturing and Inspection regarding ADL manufacturing schedule and required QC testing. Liaise with Stability Product Representatives and Product Quality Leads as required. Perform routine sample management tasks as per procedures. With a high degree of technical flexibility, work across diverse areas within QC Plan and perform multiple, complex routine/ non-routine tasks with efficiency and accuracy. Report, evaluate, back-up/archive, trend and approve data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents and equipment. Participate in audits, initiatives, and projects that may be departmental or organizational in scope. Operate and maintain GMP equipment, including responding and management of GMP alarms. Introduce new techniques/ Processes to the area, where appropriate. Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis. LIMS data coordination of commercial and import testing lots where applicable LIMS lot logging for ADL manufactured lots. Provide technical guidance, may contribute to regulatory filings. Represent the department/organization on various teams as required. Train others. Interact with outside resources. Perform general housekeeping in all sample management areas in line with 5S. Education and Experience: Bachelors degree in a Science related field is required. 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 3 years of specific sample management/ stability programme experience is desirable. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. If interested in this posting please feel free to contact Avishek Singh at Avishek.sing or for further information.
Senior QC Systems Validation Associate Hybrid RK5205 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. This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site. Key Responsibilities: Participate in process engineering activities Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows Participate in system requirement, software configuration, and design activities Receive and/or verify master data for the site(s) Coordinate ELN Template development and review with site SMEs Support the development and review of Operational Qualifications Execute User Acceptance Testing & Data Migration Verification Review and provide input on training materials Support training material development by providing inputs and reviews Support site Instrument Qualification activities such as planning and execution Education and Experience: Bachelors degree and 3 years of industry Quality Control or Quality experience GxP experience, specifically practices and requirements in the testing of biopharmaceuticals. Experience in development and validation testing of software used in a GMP environment. Experience and knowledge in using electronic lab notebook systems and inventory management systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.). Experience in the use of other industry systems such as Veeva & Empower. Experience in testing or with processes involving analytical methods. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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. This role will lead the delivery of new Formulation and Component Preparation Area within the Drug Product (DP) manufacturing portfolio, action projects as required. This role sits within the Corporate Engineering and partners closely with the Engineering Technical Authority (ETA), Site Engineering, Manufacturing, Quality, and external vendors to ensure projects are delivered safely, compliantly, on schedule, and within budget. The Project Manager will coordinate a cross functional team and is responsible for, coordinating technical, operational, CQV and External Suppliers. This role reports directly to the Engineering Technical Lead for the Formulation and Component Preparation Area. Duties: Project Leadership & Delivery Lead end to end delivery of Formulation and Component Preparation Area from design through construction, CQV, and handover to operations. Develop and manage project scope, schedule, cost, risk, and resource plans, ensuring alignment with business objectives. Cross-Functional & Stakeholder Management Act as the primary interface between ETA technical leads, site engineering, manufacturing, quality, EHS, digital, and supply chain. Coordinate and align equipment vendors, engineering firms, and contractors to ensure delivery against agreed milestones and quality standards. Compliance, Quality & Safety Ensure project execution complies with cGMP, EHS, and corporate engineering standards. Support and oversee CQV activities, ensuring readiness for commercial operation. Promote a strong safety culture throughout design, construction, and commissioning phases. Financial & Risk Management Manage capital budgets, forecasts, change control, and cost reporting. Proactively identify and mitigate technical, schedule, cost, and compliance risks. Ensure effective vendor performance management and contract execution. Digital & Sustainability Focus Integrate digital manufacturing, automation, and data strategies into project delivery. Champion sustainable design choices, energy efficiency, and resource optimization in line with companys sustainability goals. Education and Experience: 3-5+ years of experience in capital project delivery within the biopharmaceutical, pharmaceutical, or highly regulated manufacturing industry. Bachelors degree in engineering (Chemical, Mechanical, Electrical, Biochemical, Process, or related discipline), Advanced degree (MSc, MEng, MBA) is desirable but not required. Proven experience managing end-to-end facility or manufacturing area projects (concept through design, construction, CQV, and operational handover). Demonstrated experience delivering projects within GMP-regulated environments. Experience managing capital budgets, cost forecasting, changing control, and risk management for complex projects. Excellent communication and stakeholder management skills in a collaborative, matrixed environment. Direct experience supporting or overseeing Commissioning, Qualification, and Validation (CQV) activities. PMP (Project Management Professional), Chartered Engineer (CEng), or equivalent professional certification is desirable but not required. If interested in this posting please feel free to contact Avishek Singh at Avishek.sing for further information.
Continuous Improvement Coach Our client, a global biopharmaceutical manufacturer are currently recruiting for a Continuous Improvement Coach to join their team on a permanent basis. As Continuous Improvement Coach, you will support site readiness and drive continuous improvement once operations begin. The focus is on embedding Lean principles, digital transformation, and operational excellence to improve safety, quality, reliability, productivity, cost, and employee engagement. Responsibilities Facilitate the implementation and maintenance of the daily management system (DMS) utilizing digital LEAN tools Establish the integration and flow of metrics cross functionally site wide. Maintain and sustain the technical aspect of the Digital Integration Tool and Lean Management System Leverage results of systems assessment with associated feedback processes and follow-up governance mechanisms to coach key roles in the organization and implement best practices Attend all functional and flow team huddles to help offer live coaching and give feedback to identify waste or process improvement items. Ensure full integration and alignment to KPIs for each huddle area Lead the establishment of the CCI & OE systems within assigned areas, including the components and their interactions Facilitate the deployment of system standards Facilitate and execute the process of systems governance and assessment i.e., health, maturity, and performance as well as the continuous improvement of the systems Capture benefits of CCI program and report to site & executive leadership teams Contribute to the CCI&OE program strategy within the assigned area of responsibility (site/function) Collaborate with central CCI&OE function to provide input into the CCI & OE systems design Lead and / or partner on a variety of engagements, within the site/function as well as network level within Manufacturing & Quality Serve as CCI Coach partnering with Business Area Leads to facilitate the chosen methodology for the given project (e.g., Lean Lighthouse, Kaizen Event) Provide support to ensure robust Organizational Change Management and Monitoring Plans are in place to sustain improvements Engage routinely with sponsors to provide status and escalate where appropriate as issues arise Ensure Lean principles and tools are integrated into both project execution and solution design Partner with site leadership/ other functions, including site lead team and other governance forums, to identify and prioritize major productivity improvement opportunities Requirements Bachelors degree in business, engineering, science, IT, or related field 35 years experience leading improvement projects Certified Lean Six Sigma Black Belt, Master Black Belt or similar level of Lean Coach / Practitioner Certification Knowledge of Lean/CI methodologies Strong communication, problem-solving, and change management skills. Experience with digital transformation initiatives For more information please contact Sinéad Cullen on or
Business Manager (Critical Care & Medical) - Dublin Our client is a leading sales, marketing, and technical services company. They are high growth company that aims to be the partner of choice for their global healthcare suppliers. The long-term success of their sustainable business is based on teamwork, integrity, and the ability of their people to take ownership of their role. They are currently seeking a Business Manager to manage an established team. In your role, you will be required to fulfil the full range of Business Manager duties for the Critical Care & Medical ROI / NI Division. You will build and maintain a high-performance sales organisation to achieve agreed business objectives. As Business Manager you will plan, manage, and oversee the sales activities for your divisional products with the overall aim of achieving commercial goals and developing strong relationships with key opinion leaders. Territory:Field based (ROI & NI) Candidate Location: Leinster Role/Responsibilities: Develop National strategic and tactical sales and marketing plans to achieve Company objectives Establish sales objectives by forecasting annual sales targets for regions/territories, sales volume, and profit for existing and new products Prepare monthly, quarterly, and annual sales forecasts Monitor and analyse performance metrics and drive improvements Lead a team of Product Specialists Provide leadership through effective communication of vision, empowerment, and the recognition of individual and team achievement Maintain and develop team by effective recruitment, development, and training Perform field visits to develop in field sales skills as well as drive sales Establish productive and professional relationships with key supplier personnel Perform research and identify new potential customers and new market opportunities National Account Management Project Manage tenders and bids Identify and develop strong relationships with Key Opinion Leaders Develop a strong customer network Ensure that you comply with risk-assessed policies and procedures relating to IT Security, Health and Safety. Education/ Experience: Degree in Healthcare / Business Proven medical device commercial experience, with established relationships at senior level across HSE and major private healthcare customers, and a track record of converting these relationships into sustainable business growth is essential Good knowledge of sales and marketing principles Excellent ability to sell with strong customer service skills Strong communication and team management skills, with a demonstrable ability to develop people The ability to communicate effectively and to build rapport with customers at all levels Who exceeds in this role? Top performers would have: Previous experience managing a high-performance sales team Strong understanding of P&L management, margin control, and cost management down to NP1 Ability to translate financial data into actionable commercial decisions, including budgeting, forecasting, and financial performance management Performance management, coaching, and accountability setting experience Ability to manage multiple priorities and deliver results under pressure Strong work ethic and competitive drive, with a flexible and adaptable mindset Strong commercial acumen and effective planning skills and be entrepreneurial and innovative in approach Benefits associated with this role include: Competitive salary and commission structure Fully expensed company vehicle Lunch allowance Employee Assistance Program Pension, Life assurance, income protection Educational Assistance Training academy Enhanced annual and life leave Employee engagement initiatives and a dedicated internal employee communication platform Supportive colleagues to learn from and enjoy company social outings, parties, and events For further information please contact: Karen Shiel on or send CV to Skills: Sales Director Business Manager Business Unit Head
