A global healthcare leader in Ireland is seeking a Specialist in Engineering. This role involves working on diverse API projects, including product development and technology transfers. Candidates should have a degree in Chemical Engineering and at least 2 years of experience in pharmaceutical manufacturing. Join to invent solutions for unmet healthcare needs and contribute to ground-breaking innovations in a hybrid work environment. #J-18808-Ljbffr
A leading pharmaceutical company in Dundalk, Ireland, seeks a Senior QA IT Specialist to ensure the integrity and compliance of manufacturing IT systems. Responsibilities include collaboration on computerized systems, compliance with regulations, and independent quality approvals. Candidates should have a Bachelor's degree and experience in pharmaceutical automation. This hybrid role offers the chance to make a significant impact in a cutting-edge facility. #J-18808-Ljbffr
A leading biopharmaceutical company in Dunboyne is seeking a Technical Specialist Biochemistry & Cell Biology to oversee quality control testing. The ideal candidate will have a Master's degree in a relevant field, extensive experience in biochemistry and cell biology, and a strong commitment to maintaining the highest safety and compliance standards. This role includes developing and coaching the Quality Control team, supporting assay optimisation, and ensuring compliance with cGMP requirements. The company embraces a culture of safety and encourages innovative thinking. #J-18808-Ljbffr
A leading healthcare company in Dublin is seeking a Senior Clinical Trial Coordinator to oversee trial administration. Responsibilities include managing clinical documents and collaborating with clinical operations. Candidates should have 3-5 years of clinical research experience, strong MS Excel skills, and a Bachelor's degree or equivalent training. This role offers a hybrid work arrangement, fostering a diverse and inclusive environment. #J-18808-Ljbffr
A leading global healthcare company in Ireland is seeking an experienced API Maintenance Technician. You will be responsible for carrying out routine and preventative maintenance, handling equipment breakdowns, and installations to ensure operational efficiency. Ideal candidates should possess in-depth knowledge of plant equipment and maintenance practices along with strong troubleshooting skills. This position offers opportunities for innovation in a diverse workplace. #J-18808-Ljbffr
A global pharmaceutical company is seeking a DDQ Senior Specialist (QA IT) in Leinster, Ireland. In this role, you will ensure compliance and integrity of manufacturing IT systems, lead quality assurance efforts, and collaborate with various teams on capital projects. Candidates should possess a Bachelor's degree and hands-on experience in pharmaceutical manufacturing or IT systems. The company supports hybrid work arrangements, emphasizing flexibility and a commitment to diverse talent. #J-18808-Ljbffr
Job Description A fantastic opportunity has arisen for a Senior QA IT Specialist within our global Digital and Data Quality (DDQ) team. At our company, we are dedicated to ensuring the integrity and compliance of our manufacturing IT systems throughout the computerized system lifecycle. Are you ready to make a significant impact on our cutting‑edge manufacturing facility in Dundalk, Ireland? In this pivotal role, you will ensure high standards of IT system reliability, safety, and compliance within our state‑of‑the‑art live virus drug substance and drug product manufacturing facility. Your Key Responsibilities & Impact You will collaborate with System, Process, Data, and IT Owners to select computerized systems that support GMP business processes. Ensure selected technologies meet business needs, tailoring projects to fit complexity and risk. Provide independent quality approval for critical qualification and validation documentation, ensuring high standards. You’ll maintain compliance with company standards and regulations throughout the computerized system lifecycle. Verify that system owners uphold validated status with approved Operating Level Procedures/Plans. Review processes and documentation to ensure compliance with computerized systems and data integrity. Support regulatory inspections and audits, resolving nonconformance issues for GMP computerized systems and data integrity. You’ll monitor and communicate system health, compliance, and metrics updates to stakeholders, ensuring effective operation of manufacturing shopfloor systems. What We’re Looking For Required You hold a Bachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences) or equivalent. Hands‑on experience with automated systems in pharmaceutical manufacturing, IT infrastructure, or laboratory operations. Strong understanding of IT system change control, data integrity, and regulatory compliance. You possess knowledge of computerized system validation and compliance principles. Experience implementing quality systems in pharmaceutical, laboratory, or biotechnology environments. Strong analytical problem‑solving skills and the ability to integrate diverse perspectives. Project management skills, with a sense of urgency and adaptability to changing priorities. Preferred It’s a bonus if you have experience in regulatory inspection and audit activities. An advanced degree in a relevant field is likewise beneficial. Certification in project management or quality assurance is a nice‑to‑have. Required Skills Biopharmaceutical Operations Change Management Computer System Validation (CSV) Data Integrity Deviation Management GMP Compliance Manufacturing Quality Control Quality Assurance (QA) Quality Management Systems (QMS) Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Job Posting End Date 12/10/2025 Requisition ID R373883 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. #J-18808-Ljbffr
Job Description A fantastic opportunity has arisen for an Assoc. Scientist, Microbiology. This is a shift role. Bring energy, knowledge, innovation to carry out the following: Support laboratory operations within the new laboratory facility on a shift basis (primarily extended days), this may be subject to change depending on business needs. Support laboratory operations within the new laboratory facility which will include support of equipment qualification (PQ), documentation generation of SOP’s, Work instructions as well as contributing to lab and process establishment. Review, trending and reporting of laboratory data, to support generation of batch data, to collate and analyse end of quarter and year reports for all raw data generated. Maintaining and release of laboratory stock, ordering laboratory consumables where required. Manage and ensure routine cleans of laboratory equipment are completed as per site procedures, ensure laboratory housekeeping standards are maintained, identifying continuous improvement opportunities in laboratory processes. Responds to standard requests from partners, customers and clients (internal and/or external). Active participation in functional meetings, facilitation of cross-functional meetings where required. Participation in laboratory investigations and Root Cause Analysis activities. Participation in internal and external audit and inspection activities. Participation in SME development groups to improve technical expertise. Perform supporting activities for general lab operations, Run the business tasks such as EM, Facility testing, , method verifications, and execution of laboratory studies were required. A good knowledge of GMP, familiarity with USP, EP, JP requirements. Support introduction of novel, innovative solutions, supporting the testing of biologics within the facility. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Excellent troubleshooting and problem-solving skills as an individual contributor as well as collaboration skills and teamworking ability to work with global and interdisciplinary teams. Build team effectiveness skills, learn to promote team success through own actions and by demonstrating respect and appreciation for diverse populations. Support timely training completion and coaching of team members. What skills you will need: In order to excel in this role, you will more than likely have: A degree qualification in a relevant field (Biological Sciences/ Engineering), preferable for background in microbiology. A minimum of 1-3 years experience working in a relevant academic or industry field, (Internships and student placements will be considered in lieu of experience). Ability to work as part of a team and on own initiative in a constructive manner. Knowledge with Biologics manufacturing and familiarity with microbiological testing techniques. Knowledge of laboratory systems (e.g. LIMS, E-logs, MODA, and electronic notebooks). Ability to think logically and be proactive under pressure. Effective communicator and technical expertise in science, to be able to share and communicate that knowledge through training other analysts. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Required Skills: Accountability, Accountability, Biochemical Assays, Business Management, Business Operations, Clinical Microbiology, Communication, Data Analysis, Detail-Oriented, Dosage Forms, Drug Product Development, GMP Compliance, High-Performance Liquid Chromatography (HPLC), Instrument Calibrations, Laboratory Analysis, Laboratory Maintenance, Laboratory Techniques, Microbiological Techniques, Molecular Structure, Motivating Teams, Project Management, Qualitative Analysis, Risk Assessments, Safety Culture, Site Safety {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/3/2025 Requisition ID: R374233 #J-18808-Ljbffr
A leading global healthcare company in Ireland seeks an Assoc. Scientist in Microbiology. This shift role involves supporting laboratory operations, handling data reporting, and ensuring quality standards are met. Ideal candidates have a degree in Biological Sciences/Engineering and relevant experience, including internships. Join our diverse team and contribute to innovative solutions in healthcare. #J-18808-Ljbffr
Job Description A fantastic opportunity has arisen for a Technical Specialist Biochemistry & Cell Biology in our Dunboyne facility. This individual will be responsible for quality control support testing by providing technical expertise for the following activities: method execution troubleshooting, establishment of methods, input in investigations, building capability related to Biochemistry and Cell Biology methods and Analytical methods in Dunboyne Biologics. Responsibilities Develop lead and coach the Quality Control team in relation to the technical aspect of the lab activities and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals. Support the performance and optimisation of advanced assays requiring precise analytical skills and an understanding of biological and chemical principles. Review, evaluate, and approve Analytical Testing data. Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead. Use sophisticated laboratory instrumentation and Global LIMS or other computerized systems for collecting, recording, and approving test data/results. Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. Works under minimal supervision. Ensure area is always maintained in a GMP state while following all EHS and 5S guidelines. Prepare and update SOPs as required. Apply Lean principles such as 5S throughout daily work activities. Ensure personal training requirements are met and that training records are current. Train staff as per business needs. Drive the development of technical skills through coaching and motivate a high performing culture across the team. Demonstrate a commitment to learning and personal development. Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions. Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation. Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable. Execute company policies. Support the preparation of laboratory protocol studies/validations as required. Familiarity with code of federal regulations, and compendia requirements. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations. Get actively involved by participating in inspections, GEMBA’s and Go-See’s. Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture. Consistently deliver on specific area Key Performance Indicators. Operate to the highest standards of Safety, Quality, and Compliance. Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts. Routinely talk about any safety issues you are concerned about. Know the hazards of the tasks you are performing, actively conduct risk assessments for inclusion into operational SOPs. Challenge yourself before starting any task and identify safety improvements and be an active participant of our site safety standards challenging the status quo. Challenge and identify improvements to the safety and environmental programmes on site. Ensure you are effectively trained for the work you need to do, challenge the safety training if it is not effective. Promote an environment where everyone speaks up for our culture of safety and looks out for one another. Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities. Be a visible leader of safety initiatives and stay actively involved in safety forums. Celebrate with use of proactive recognition tools that inspire teams and individuals you can collaborate with. Provide coaching for the team members as part of the continuous improvement mindset. Role model the behaviours that create a culture of dignity and respect. Encourage new and innovative approaches to improve the value stream. Utilise real-time data analytics for making decisions on the value stream improvement initiatives. Engage in implementing innovative solutions that drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals. Engage in other tasks as required. Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation. What skills you will need In order to excel in this role, you will more than likely have: A Master’s degree qualification in Science/Quality/Technical disciplines with 5 years’ experience in the biotechnology and/or pharmaceutical industry (preferably both) or PhD with 3 years’ experience. Leadership skills and experience managing daily activities. Preferably Lean Six Sigma experience. Excellent written and oral communication skills. Strong understanding of cGMP requirements for manufacturing and/or systems and compliance. Required to work on their own initiative in a constructive manner in addition to working as part of a team. Excellent time management and organisational skills. Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills. Strong understanding of GMP, ICH, USP and global compendia regulations and guidance, particularly as related to analytical method development and validation. Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc). Excellent troubleshooting and problem solving skills. Ability to think logically and be proactive under pressure. Flexible and self‑motivated. About the Company As a company, we are committed to keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application. Ready to Apply? Invent solutions to meet unmet healthcare needs, please apply today. Required Skills Accountability, Adaptability, Aseptic Manufacturing, Assay, Biochemical Assays, Biotechnology, Cell-Based Assays, cGMP Compliance, Data Analysis, Decision Making, Documentation Review, Enzyme Linked Immunosorbent Assay (ELISA), FDA Regulations, GMP Compliance, Hardware Implementation, Integrity Management, Interpersonal Communication, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Oral Communications, Quality Inspections, Quality Operations, Regulatory Compliance. Current Employees Current Employees apply Current Contingent Workers Current Contingent Workers apply Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Requisition ID R366532 #J-18808-Ljbffr
