A leading pharmaceutical company is seeking an Associate Director for Quality Assurance to enhance compliance at their Ballydine site in Ireland. The successful candidate will provide leadership and support to ensure adherence to Good Manufacturing Practices. Candidates should hold a relevant degree and possess over five years of experience in the pharmaceutical industry, demonstrating strong auditing, collaboration, and continuous improvement skills. Applicants ready to innovate and enhance healthcare are encouraged to apply. #J-18808-Ljbffr
Associate Director, Quality Assurance page is loaded## Associate Director, Quality Assuranceremote type: Not Applicablelocations: IRL - Tipperary - Ballydinetime type: Full timeposted on: Posted Todaytime left to apply: End Date: January 5, 2026 (23 days left to apply)job requisition id: R376246Job DescriptionAn amazing opportunity has arisen for an Associate Director Quality Assurance at our Ballydine site. You will report to the Quality Director and partner with the Quality Leadership Team to ensure our Drug Substance, Spray Dried Intermediate, and Drug Product are compliant and ready for downstream customers. This is a hands-on, people-centered role where your leadership, judgment, and commitment to continuous improvement will make a real impact.**Bring energy, knowledge, innovation to carry out the following:*** Provide Quality support to the Integrated Process Teams to ensure the facility meets and operates to all Good Manufacturing Practice (GMP) requirements for development, clinical and commercial supply.* Participate as a team member in the Documentation Review and Approval Process, Deviation Management Process, Quality Risk Management, Change Control Management and New Product Introduction.* Lead and support GMP audits and regulatory inspections (internal, customer, regulatory). Serve as lead auditor for walkdowns and systems audits to maintain compliance and continuous inspection readiness.* Accountable for the development and performance of the team, providing input and coaching on professional development. Provide timely feedback and ensure that responsibilities are delivered following appropriate inclusion principles & behaviours.* Lead and support Continuous Improvement of Quality and site processes.**What skills you will need:**In order to excel in this role, you will more than likely have:* Degree or post graduate qualification in Science, Pharmaceutical or Engineering field.* Minimum of 5-year experience in the Pharma regulated industry with leadership experience; clinical and commercial GMP experience preferred.* Excellent knowledge of regulations and sources of regulatory information.* Experience with regulatory inspections.* Qualified Person qualification is an advantage.* Experience in High Potency Manufacturing, Continuous Manufacturing, Spray Drying, Laboratory GMP and Project Management is desirable.* Demonstrated continuous improvement mindset and capabilities.* Dynamic individual with excellent organizational skills, who can effectively collaborate with cross functional teams.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.**So, if you are ready to:**Invent solutions to meet unmet healthcare needs, please **apply today**.**Required Skills:**Auditing, Collaboration, Continuous Improvement, Leadership, Quality Assurance (QA), Quality Management Systems (QMS), Regulatory Inspections, Risk Management**Preferred Skills:**Current Employees applyCurrent 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**Relocation:****VISA Sponsorship:****Travel Requirements:****Flexible Work Arrangements:**Not Applicable**Shift:****Valid Driving License:****Hazardous Material(s):****Job Posting End Date:**01/5/2026**\*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
A leading health company in Ireland is seeking an Automation Engineer to lead efforts in developing innovative methodologies for automation systems. The ideal candidate will have over 5 years of experience in the biotech or pharmaceutical industry. Responsibilities include providing technical support to ensure stable operations, maintaining compliance, and leading continuous improvement initiatives. The role requires collaboration across teams to drive performance in a dynamic environment, making it suitable for individuals who thrive in team settings. #J-18808-Ljbffr
Automation Engineer page is loaded## Automation Engineerremote type: Not Applicablelocations: IRL - Meath - Dunboynetime type: Full timeposted on: Posted Todaytime left to apply: End Date: January 17, 2026 (30+ days left to apply)job requisition id: R375584Job DescriptionAn opportunity has arisen to join our team as an Automation Engineer and take the lead in developing innovative methodologies for managing automation systems in a high-performance team setting! If you have a passion for compliance, vendor management, and solving automation challenges, we want to hear from you.This role is part of our Digital Manufacturing Operations (DMO) Team in our multi-product biotech facility in Dunboyne. The Automation Engineer works across the site Self-Directed Work Teams and hub teams to identify and resolve issues in order to allow the site to achieve our Governance Pillars in EHS, Quality, Value, People and Delivery. This role will be part of a team responsible for systems engineering and for provision of operational and technical support to the site.**What you will do:**Bring energy, knowledge, innovation and leadership to carry out the following:* Provide manufacturing execution systems, automation and technical support to ensure stable, efficient and robust operations at the site.* Maintains the areas automation systems in an inspection-ready, GMP compliant state. Actively participates in audits as required.* Anticipate, solve or escalate problems as appropriate and provide timely updates.* Support escalation plan for routine and out of hours emergencies and response.* Work collaboratively on resolving obstacles and building relationships so as to maintain a highly effective and productive work environment.* Investigate events and non-conformances and complete technical reports as appropriate, identify improvement opportunities, perform technical troubleshooting and successfully implement solutions.* Control, develop and modify all automation system process recipes, phases, base layer and Operator Interface.* Review and approve changes to operating procedures and the change control process relating to the systems.* Identify opportunities, design and implement solutions to enhance the digital and paperless vision for the site.* Get actively involved by participating in inspections, GEMBA’s and Go-See’s.* Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.* Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.* Challenge and identify improvements to the safety and environmental programmes on site.* Promote an environment where everyone speaks up for our culture of safety and looks out for one another.* Provide coaching for your team members as part of the continuous improvement mindset and Role model the behaviours that creates a culture of dignity and respect.* 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:* 5+ Years experience in the biotechnology and/or pharmaceutical industry desirable.* Experience with current industry platforms required (Production Automated Systems, Building Automated Systems, Manufacturing Automated Systems, Manufacturing Execution Systems, Data Historians, PLCs).* Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.* Proven record of accomplishments in a regulated industry.* Must enjoy working in a team-based environment.* Prior Automation experience is not considered essential for the right candidate – Bioprocess Engineering, Process Operations experience in an automated environment etc. will be considered.* Minimum of a bachelor’s degree in a relevant field e.g. Biotechnology, Automation, Mechatronics, Chemical Engineering etc.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.**So, if you are ready to:**Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, **please apply today.****Required Skills:**Accountability, Audit Management, Automation, Business Process Improvements, Coach Team Members, Communication, Data Management, Digital Manufacturing, GMP Compliance, Lean Management, Manufacturing Execution Systems (MES), Manufacturing Operations, Mechatronics, Methodical Approach, Pharmaceutical Management, Problem Management, Quality Management, Real-Time Programming, Risk Assessments, Safety Training Programs, Software Development Life Cycle (SDLC), Systems Engineering**Preferred Skills:**Current Employees applyCurrent 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**Relocation:****VISA Sponsorship:****Travel Requirements:****Flexible Work Arrangements:**Not Applicable**Shift:****Valid Driving License:****Hazardous Material(s):****Job Posting End Date:**01/17/2026**\*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
A leading biopharmaceutical company in Dunboyne is seeking a Bioprocess Engineering Manager to oversee a team and lead key technology transfer activities. Candidates should have a Bachelor’s degree in a technical field and a minimum of 6 years of experience in a biopharmaceutical environment. The role involves mentoring, optimizing processes, and ensuring compliance with industry standards, making it a pivotal position in the company's innovative efforts in healthcare. #J-18808-Ljbffr
Bioprocess Engineering Manager page is loaded## Bioprocess Engineering Managerremote type: Not Applicablelocations: IRL - Meath - Dunboynetime type: Full timeposted on: Posted Todaytime left to apply: End Date: December 25, 2025 (13 days left to apply)job requisition id: R377046Job DescriptionAn amazing opportunity has arisen for a **Bioprocess Engineering Manager** to join our high preforming MS&T team in our state-of-the-art, single use multiproduct facility in Dunboyne, Co. Meath.**Key responsibilities will include**:* Oversee and mentor a team of engineers and scientists within the MS&T department, fostering a collaborative and high-performance culture.* Responsible for leading key technology transfer activities in support of clinical and commercial new product introduction projects.* Develop strategies for and support the execution of technology transfer, process, and cleaning validation programs in line with company, industry, and regulatory standards.* Function as a process Subject Matter Expert in support of process investigations and provide guidance to team members.* Utilize risk management techniques to assess strategies, prioritize activities, and initiatives.* Lead significant business-critical projects on-site associated with new product introduction and site capability build.* Support the coaching and professional development of other members of the MS&T team, ensuring continuous learning and skill enhancement.* Responsible for the use of process engineering systems and approaches for equipment design, specification and performance, generation of technical reports, process modelling, risk management, and integration of process equipment systems.* Drive the ongoing optimization of process equipment and development of future breakthrough business solutions.**Your profile**:* Minimum of a Bachelor’s Level 8 degree in a technical field (e.g., Engineering, Science, or equivalent), with experience in the biotechnology or pharmaceutical industry.* Minimum of 6 years in a biologics drug substance environment.* Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.* Experience in technology transfers for clinical or commercial biologics strongly desired.* Experience with automated systems (PAS, MES) highly desired.* Process validation and cleaning validation experience desired.* Proven ability to manage multiple priorities and know when to escalate for resolution.* Flexible and self-motivated, with a proven ability to work cross-functionally to deliver technical solutions to issues.* Ability to travel internationally as the role will have a minimal travel requirement (approx.
A leading biopharmaceutical company in Dunboyne seeks a Senior Scientist for the Biochemistry team. This laboratory-based role involves solving analytical problems to support Biologics product development. The successful candidate will collaborate in a multidisciplinary environment and hold a Ph.D. or relevant experience in analytical chemistry. The position offers opportunities for coaching and mentoring fellow scientists in a dynamic and cutting-edge facility. #J-18808-Ljbffr
Job DescriptionOur Company in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.Our site in Dunboyne serves as a magnetic force that attracts, recognises, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in our Company in Dunboyne, but that the facility belongs to and is shaped by them.The Biologics Analytical Research & Development department is seeking applicants for a Senior Scientist position within the Biochemistry team. This is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.The Senior Scientist is expected to be a subject matter expert during execution of assay validations with expertise in analytical problem solving. **Main areas of responsibility include:*** Review execution of analytical method validations and transfers (among different Company sites, and between our Company and CROs) and write technical protocols and reports.* Review and execution of analytical testing of drug substance release, stability and characterisation for biologics under GMP/GDP.* Analyse and optimize current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.* Review execution of analytical method validations and transfers (among different Company sites, and between our Company and CROs) and write technical protocols and reports.* Technical Troubleshooting & Optimisation to support seamless method qualification.* Collaborate with a global network of scientists to streamline and platform scientific methods entering Biologics AR&D at our Company in Dunboyne.* Review and approval of analytical methods, SOPs and other documentation.* Support Quality Events to ensure execution in Biologics AR&D is compliant to GMP standards.* Works in accordance with applicable internal company regulations: safety, health and environmental protection.* Coaching and mentoring for Scientists within the department.* Ensure proper maintenance of the equipment, including calibration and qualification work. Leads functional area teams or technical forums with direct pipeline impact.**Required Education:*** Ph.D. in Analytical Chemistry/Biochemistry or related field or MSc with a minimum of 3 years of experience in the Biopharmaceutical Industry or Bachelor with 7 years of experience in the Biopharmaceutical Industry.**Required Experience and Skills:*** GMP working experience and a working knowledge of regulatory requirements.* Experience with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique.* Ability to review and/or execute the qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.* Knowledge of Analytical Methodologies and sound scientific understanding of Critical Quality Attributes as well as data analysis and statistics for setting specifications.* Expertise in method validations and technology transfers.* Effective organisational and multi-tasking skills with strong oral and written communication skills.* Team player with ability to support peer to peer coaching and lead technical discussion with subject matter experts, Operations, Quality.* Applies strong scientific and technical knowledge to shape and deliver on pipeline innovation.* Leverage broad expertise to drive strategic, therapeutic, regulatory and scientific goals.* Partners with Management to develop and execute scientific and enterprise strategy.* Models and inspires a culture of collaboration, diversity & inclusion.* Strong commitment to coaching, mentoring, and training Scientists.**Preferred experience and skills:*** Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.* Understanding of current manufacturing processes.* Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion proteins, etc.).* Certified in Lean Six Sigma or experience in Quality by Design.**Required Skills:**Accountability, Adaptability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Assays, Cell-Based Assays, Chromatographic Techniques, Communication, GMP Environments, Innovative Thinking, Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Strategic Thinking, Team Management, Technical Writing, Ultra Performance Liquid Chromatography (UPLC)**Preferred Skills:**Current Employees applyCurrent 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**Relocation:****VISA Sponsorship:****Travel Requirements:****Flexible Work Arrangements:**Not Applicable**Shift:****Valid Driving License:****Hazardous Material(s):****Job Posting End Date:**12/25/2025**\*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
A leading biopharmaceutical company in Dublin is seeking a Process Scientist to deliver technical expertise in cell culture technology. The role involves troubleshooting bioreactors, optimizing bioprocesses, and supporting regulatory submissions. Ideal candidates will hold a degree in Biological Sciences or related fields and have experience in the biopharmaceutical industry with small-scale bioreactors. This position promotes a hybrid working model and emphasizes a commitment to research and innovation in healthcare solutions. #J-18808-Ljbffr
Process Scientist (Shift) page is loaded## Process Scientist (Shift)remote type: Not Applicablelocations: IRL - Dublin - Swords (Biotech)time type: Full timeposted on: Posted Yesterdaytime left to apply: End Date: December 15, 2025 (11 days left to apply)job requisition id: R366058Job DescriptionA fantastic and exciting opportunity has arisen for a **Process Scientist** in the field of cell culture technology as part of Manufacturing Science and Technology Laboratory Team. The role will deliver a diverse range of technical expertise and support to the business. The ideal candidate will have hands-on experience operating and troubleshooting bioreactors.**Bring energy, knowledge, innovation to carry out the following:*** Leading, designing, promoting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations using small scale models.* Process improvement and troubleshooting with end-to-end product focus.* Execute and optimize upstream bioprocesses using bioreactors, including culture setup, monitoring key parameters* Supporting the industry 4.0 initiative to navigate operations in a digital environment.* Provide technical support investigations, new process introduction or change implementation in commercial manufacturing operations.* Supporting global regulatory submissions as needed.**In order to excel in this role, you will more than likely have**:* A degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.* Hands-on experience operating small-scale bioreactors **(
