MSD Malaysia is seeking a Senior Specialist, External Quality to manage quality assurance processes for pharmaceutical products. This remote position involves acting as a Qualified Person for batch certification and leading quality improvement projects. Candidates should hold a relevant degree and have at least 5 years of experience in the pharmaceutical industry. Strong skills in Quality Assurance, regulatory compliance, and problem-solving are essential. This role is critical in ensuring adherence to regulatory standards and effective collaboration. #J-18808-Ljbffr
## Senior Specialist, External QualityApplyremote type: Remotelocations: IRL - Tipperary - Ballydine: IRL - Dublin - Leopardstown (Red Oak): ESP - Madrid - Madrid (Josefa Valcarcel): FRA - Auvergne-Rhone-Alpes - Clermont Ferrand (Turing 22): ITA - Lazio - Romatime type: Full timeposted on: Posted 8 Days Agotime left to apply: End Date: May 15, 2026 (6 days left to apply)job requisition id: R395796Job DescriptionPosition OverviewIndividual contributor role responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in conformance with all applicable regulatory requirements, regulatory filings and company policies. Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release of API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals. Essential Functions and Responsibilities (Includes, but are not limited to)The Sr Specialist, External Quality, is responsible for:Primary functions and responsibilities of the role:* Act as Qualified Person (QP), where applicable, to certify the batches of Finished Good products to be released in the EU Market under requirements of European Laws & applicable regulations* Support New Product Introduction and other process transfer/validation activities at partner sites, where required* Act as delegate for EQA Associate Director roles, when required* Evaluate and/or release products with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations* Manage/coordinate internal and external partner deviations and complaints as required, assist in the coordination of significant investigations including Fact Findings and RCA, risk assessment support on critical issues to prevent disruption to supply* Review and approve changes to master batch records* Act as owner for change controls and change tasks, as required* Support collection and compilation of documentation needed for regulatory filings/submissions, when required* Operate in a safe and efficient manner and in compliance with the Safety and Health PolicyThe Sr. Specialist, External Quality is also responsible for:* Initiate & lead quality improvement projects, new Quality Systems introduction and other assignments, as per business needs* Provide training and coaching, as required* Collaborating with internal and external stakeholders, EQA Compliance Team and other ExN Platforms as part of cross-organizational engagement approach* Participating in external partner site visits and GEMBA, as required, as part of ongoing EQA oversight activities* Serves as Quality SME for EQA; Maintains and provides expertise on EQA quality and/or business systems, tools, data, and processes on an ongoing basis* Amount of Travel Required:
Operations Director page is loaded## Operations Directorremote type: Not Applicablelocations: IRL - Meath - Dunboynetime type: Full timeposted on: Posted Todaytime left to apply: End Date: May 13, 2026 (6 days left to apply)job requisition id: R395948Job DescriptionA fantastic and hugely exciting opportunity has arisen for an **Operations Director** for Biologics clinical and commercial manufacturing at our single-use, multi-product commercialization facility in Dunboyne. Reporting to the Operations Lead, this position will drive capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex biologics pipeline. This role will have leadership for one of the manufacturing areas (Upstream/Cell Banking, Downstream, and Solution Prep) spanning multiple facilities across the site, enabling standardization and simplified ways of workings for optimal utilization and resource agility. This position will provide leadership and operations support for manufacturing and release in addition to technology transfer, PPQ, inspection readiness and approval of new products. This position will include leadership across the organization, including days and shift teams.Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing a significant role in helping to commercialise key medicines. The innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.**Key responsibilities*** Responsible for all Manufacturing Operations used for clinical and commercial manufacture Prep activities.* Plans and directs all aspects of production activities associated with manufacturing or technology transfer and ensures that all projects, initiatives, and processes are in conformance with established policies, standards, and objectives.* Develop and delivers toward site and organizational priorities and strategy.* Ensure right-first time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements.* Drive a strong compliance mindset within the organisation, including initiative-taking safety and quality culture, and adherence to all regulatory expectations.* Ownership for ensuring permanent inspection readiness is in place.* Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule.* Establish and deliver on KPI’s in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure.* Drive standardization, execution, and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model.* Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward, and develop diverse talent with the capabilities necessary to succeed in manufacture.* Develop facility and resource capacity model across areas within scope. Resolve resource and prioritisation constraints and support resource needs and changes.* Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes.* Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders.* Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process.* Provide clear direction and definition of any new project scope, goals, and deliverables, to the site and cross-functional sub-teams on an on-going basis.* Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders.* Manage financial forecasts and workload to achieve departmental headcount and cost improvements.**Your profile**Minimum Education/Experience:* Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies).* Demonstrated leadership with at least 10 years leading in a cross-functional manufacturing environment, including indirect or direct people management experience.* Demonstrated Biologics manufacturing and technology transfer experience.Technical/General Competencies:* Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high-performance organizational culture that accommodates rapid growth & highly dynamic operating execution.* Inspirational leader that leverages data to set the vision and drive outcomes.* The desire to continuously learn, improve and grow, and cultivate continued development within the team.* Innovative thinker, with excellent decision-making and problem-solving skills.* Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of our site in Dunboyne.* Ability to influence across organizational layers, as well as outside the site and externally with partners and based on industry benchmarking.* Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives.* A great communicator, decisive decision maker with a proven ability to deliver excellence.* Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track-record in project management.* Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes* Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.* Knowledge of global and company health authority regulations and applicable systems & GMP requirements. Experience engaging with regulatory agencies including in on-site inspections.* Sound judgment and comfortable operating in a challenging, fast-paced, and sometimes ambiguous environment.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.**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:**Adaptability, Adaptability, Business Agility, Data Analysis, Decision Making, Driving Continuous Improvement, Financial Forecasting, Lean Design, Lean Manufacturing, Manufacturing Processes, Manufacturing Quality Control, Mitigated Risks, Operational Excellence, Operations Support, Organizational Culture, People Leadership, Process Optimization, Production Scheduling, Project Management, Regulatory Compliance, Results-Oriented, Risk Mitigation Strategies, Six Sigma, Sterile Manufacturing, Strategic Initiative {+ 2 more}**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 #J-18808-Ljbffr
MSD Malaysia is seeking a Specialist, Safety & Environment to join our EHS team in Dunboyne, Ireland. This role includes developing EHS programmes, ensuring compliance with regulations, and supporting operational departments. Ideal candidates will have significant EHS experience in regulated industries and a relevant educational background. The position offers a unique opportunity to impact health, safety, and environmental practices in a cutting-edge facility that plays a key role in the pharmaceutical sector. #J-18808-Ljbffr
Job DescriptionAn amazing opportunity has arisen for a **Specialist, Safety & Environment** to join the Environmental Health & Safety (EHS) team, state-of-the-art, single-use multiproduct facility in Dunboyne, Co. Meath.In this role, you will play an integral part in developing, maintaining, and continually improving the EHS systems. You will provide technical guidance to ensure compliance with legal requirements and our company's corporate standards, policies, procedures, and guidelines related to EHS and industry best practices.This is a compelling position for a dynamic and ambitious EHS professional looking to make a significant impact.**What you will do:**Bring energy, knowledge, innovation and leadership to carry out the following:* Develop, implement, and maintain EHS programmes to ensure compliance with local legislation, company standards, and industry best practices.* Ensure site environmental compliance against all regulatory, EPA permitting and legal requirements.* Evaluate EHS systems, programs and procedures for compliance and improvement by reviewing, auditing, and carrying out inspections.* Manage day-to-day EHS queries, technical support, and machine/plant/process or equipment safety issues.* Support operational departments in achieving and establishing compliance.* Demonstrate a strong desire to protect employees, our community, and the environment in an EHS world-class facility – leading with a 'safety first' mindset.* Prepare relevant reports to site, divisional and/or corporate management and regulatory agencies.* Maintain a high standard of documentation in relation to all activities.* Evaluate all EHS applicable requirements for any new projects and processes (along with other site departments where necessary) as well as changes in the existing processes and installation.**What skills you will need:**In order to excel in this role, you will more than likely have:*Required** Demonstrated EHS experience in highly regulated industry.* Experience in supporting multiple activities/projects.* Experience in managing and implementing change.* Strong ability to influence all levels of the organization and cross-functional teams locally.* Technically strong; with understanding of a variety of EHS topics.* Innovative and compliance-minded, with the drive to seek out necessary information.* Safety First, Quality Always and Inclusion for All mindset. Desire to protect employees and environment.*Preferred** Level 8 of education in EHS field of study or certification equivalence.* EHS experience in Biologics/Pharmaceuticals.* An understanding of Environmental Management and Industrial Emissions Licencing.* Experience in Contractor Management.* Experience with High-Risk Work ProgrammesWithin our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from our Company in Ireland to the world.**Our Commitment to Ireland:**Our Company is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and varied team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company’s top products, helping save and enhance lives in over 140 countries around the world.**Our facility in Dunboyne** joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialization Facility, playing an important role in helping to commercialize key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring medicine to market for the benefit of patients around the world.**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:**Biosafety, Driving Continuous Improvement, EHS Auditing, EHS Compliance, Incident Investigations, Process Safety, Regulatory Compliance, Waste 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:**No relocation**VISA Sponsorship:**No**Travel Requirements:**No Travel Required**Flexible Work Arrangements:**Not Applicable**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**N/A**Job Posting End Date:**05/16/2026**\*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
MSD Malaysia is seeking an Associate Specialist in Engineering for their Ballydine facility in Ireland. This role involves contributing to drug product projects, process development, and providing technical support for manufacturing activities. Candidates should have 1-3 years of relevant experience, strong communication skills, and a degree in Chemical Engineering. The position is full-time, and hybrid work arrangements are discussed during the application process. #J-18808-Ljbffr
Chemical Engineer-6 page is loaded## Chemical Engineer-6remote type: Not Applicablelocations: IRL - Tipperary - Ballydinetime type: Full timeposted on: Posted Todaytime left to apply: End Date: May 14, 2026 (13 days left to apply)job requisition id: R395073Job DescriptionAn amazing opportunity has arisen for an **Associate Specialist, Engineering.**This is an exciting and challenging opportunity to work on multiple Drug Product projects, contributing to product development and scale-up, new product introductions and technology transfers, as well as manufacturing support activities.This position is for an Engineer in the Commercialisation, Development and Supply (CDS) group. This group is responsible for process development of Active Pharmaceutical Ingredients (API), Oral Solid Dose (OSD) and potent products from Phase IIb through regulatory filings, process validation, and into the first few years of commercial launch. The group is part of the Global Pharmaceutical and Commercialization (GPC) organization and collaborates with colleagues across the globe on developing new products.First established in 1976, our Ballydine facility develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. Ballydine was our Company’s first site in Ireland, the Ballydine site is our Company’s primary small molecule pipeline commercialisation facility globally, operating as a European hub for quality, manufacturing, and engineering. Its highly skilled teams lead the way in the development of new medicines, including innovative treatments for Hepatitis C, HIV and immuno-oncology, the site exports to over 25 countries around the world.**Bring energy, knowledge, innovation to carry out the following:*** Plan, conduct, evaluate and interpret process development studies, including scale-up, OSD/Spray drying characterization, and design space development.* Clinical and formal stability batch manufacture,* Leading and participating in cross functional teams to carry out Quality Risk Assessments, Quality Investigations, and Safety Assessments.* Process validation.* Problem-solving skills are essential and knowledge of concepts of Quality by Design, including risk-based approaches to development, design of experiments, and process modelling, are desired.* Support commercial supply activities such as* Process and cleaning recipe and documentation preparations.* Technical support to production and cleaning campaigns.* Trouble shooting, investigations and documenting process issues and deviations.* Identifying and implementing process improvement and optimization opportunities.* Other responsibilities include data analysis, technology evaluation, and compliance with applicable safety and current good manufacturing practices.**What skills you will need:**In order to excel in this role, you will more than likely have:* Minimum of 1- 3 years relevant experience in Oral Solid Dosage or Spray Drying.* Strong oral communication skills* Proficiency in technical writing.* Work independently and deliver work task on time.* Bachelors or postgraduate degree in Chemical or Process Engineering or a Science related disciplineWe 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:**Chemical Engineering, Data Analysis, Engineering Design, Engineering Standards, Estimation and Planning, Industrial Engineering, Manufacturing Equipment, Manufacturing Scale-Up, Problem Solving, Process Improvements, Professional Engineering, Project Management, Self Motivation, Teamwork, Technical Writing**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:**No relocation**VISA Sponsorship:**No**Travel Requirements:**10%**Flexible Work Arrangements:**Not Applicable**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**N.A**Job Posting End Date:**05/14/2026**\*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
MSD Malaysia in Dunboyne is seeking a Senior Manufacturing Bioprocess Associate to provide operational support for the Late Stage and Launch Pipeline at our advanced biotechnology facility. This role requires a Level 6 qualification and a minimum of 3+ years in GMP Manufacturing. Responsibilities include supporting production operations, operating equipment as per records, and adhering to safety and compliance standards. Join us in our mission to excel in biopharmaceutical manufacturing. #J-18808-Ljbffr
We are seeking a **Senior Specialist (QRM & Auditing)** to play a key role within our **Global Development Quality Assurance** team at our BioNX R&D facility in Dunboyne. In this role, you will lead the site’s Quality Risk Management and Auditing programmes, help shape a culture of continuous improvement, and mentor more junior QA colleagues.- Ensure compliance with global and regulatory QMS requirements, including: * Quality Manual * Change Control * Deviation Management * Supplier Quality Management * Quality Risk Management * Audit Management and associated electronic systems* Participate in global and local Communities of Practice for QRM and Auditing* Work collaboratively with cross‐functional partners to drive a safe, compliant and proactive quality culture in BioNX* Perform additional duties as assigned by your manager/supervisor* At least **5 years of experience** in a GMP environment within pharma/biotech, ideally in a QA, QRM or auditing role* Solid understanding of Quality Risk Management, audit processes, and inspection readiness* Experience working with quality systems (e.g., deviations, change control, CAPA, supplier quality) and associated electronic tools* Ability to interpret and apply global and regulatory quality requirements* Proven ability to influence, train and mentor others* Strong communication, stakeholder management and collaboration skills #J-18808-Ljbffr
Manufacturing Bioprocess Associate page is loaded## Manufacturing Bioprocess Associateremote type: Not Applicablelocations: IRL - Meath - Dunboynetime type: Full timeposted on: Posted Todaytime left to apply: End Date: May 13, 2026 (14 days left to apply)job requisition id: R395262Job DescriptionAn amazing opportunity has arisen for a **Manufacturing Bioprocess Associate**, in Dunboyne.In this shift role (12/7), you will provide operational support for shop floor operations of the Late Stage and Launch Pipeline, at our new state of the art single use biotechnology facility.At our company, we aspire to be the premier research-intensive biopharmaceutical company. Our Biologics facility in Dunboyne is a state-of-the-art facility that integrates leading-edge technology with a dynamic workspace to support seamless connection and collaboration. BioNX provides Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch, operating in a multi-product mode to adapt to changing demands.**What you will do:*** Support end-to-end production operations for both Fed Batch and Continuous Manufacturing.* Operate equipment according to electronic batch records, sampling plans, and standard operating procedures.* Support weekend or out-of-hours work on select time frames to support manufacturing activities.* Conduct all work activities with strict adherence to the safety and compliance culture on site.* Support the authoring of electronic batch records, sampling plans, work instructions, and standard operating procedures.* Work as part of a multi-disciplined, diverse, and dedicated process team where flexibility and teamwork are essential requirements.**What skills you will need:**In order to excel in this role, you will more than likely have:*Required** Level 6 qualification in a science or engineering discipline.* 2+ years of experience in a GMP Manufacturing environment.* Ability to work independently and within a cross-functional team.* Familiarity with contamination control and batch release requirements.* Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.*Preferred** Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing process.* Experience with various SingleUse technologies in a manufacturing environment.* Knowledge in cell expansion and or, cell banking operations.**Required Skills:**Adaptability, Adaptability, Analytical Thinking, Applied Engineering, Automation, Cleanroom Gowning, Cognitive Flexibility, Computer Literacy, Contamination Control, Equipment Set Up, Fabrication Processes, GMP Environments, GMP Operations, Good Manufacturing Practices (GMP), In-Process Control (IPC), Manufacturing Environments, Manufacturing Processes, Manufacturing Support, Mechatronics, Problem Resolution, Process Manufacturing, Production Scheduling, Recordkeeping, Standard Operating Procedure (SOP) Management, Sterile Manufacturing {+ 2 more}**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:**05/13/2026**\*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
