Job Description A fantastic opportunity has arisen for a Lead Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland. Our facility in Dunboyne, Co. Meath 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. Our Dunboyne facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. Our Dunboyne facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them. Bring Energy, Knowledge, Innovation To Carry Out The Following Lead/Guide team members within a process team in one or more unit operations. Provide guidance, coaching and mentoring to the rest of the production team. Operate equipment according to electronic batch records, sampling plans and standard operating procedures. Work as part of a dedicated process team where flexibility and teamwork are a key requirement. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Support weekend or out of hours work on select time frames to support manufacturing activities. Conduct all work activities with a 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. Lead, facilitate and participate daily on cross-functional teams to collaboratively cover compliance topics. What Skills You Will Need In order to excel in this role, you will more than likely have: Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. 5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Competent in troubleshooting and show practical problem-solving capabilities. Ability to work independently and within a cross-functional team. Understanding of multi column chromatography concepts. Familiarity with contamination control and batch release requirements. Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process. Proficiency in various Single Use technologies in a manufacturing environment. Problem, Deviation, and Change Management experience. Preferred Experience and Skills: Commissioning and Qualification experience. Experience of Upstream and Downstream Unit Operations for mAb manufacturing with in depth knowledge of key unit operations. Understanding of both continuous and batch fed manufacturing processes. Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits. 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. 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: Flexible Work Arrangements Not Applicable Shift Valid Driving License: Hazardous Material(s) Job Posting End Date: 04/24/2025 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. Requisition ID: R342275 #J-18808-Ljbffr
Job Description About the Role An amazing opportunity has arisen for an External Manufacturing Operations Senior Specialist. This role is essential in ensuring customer demand is met through a seamless partnership with our External Partners. You will be accountable for excelling in compliance, supply management, continuous improvement, and cost efficiency through effective leadership and coaching of cross-functional teams. What You Will Do Relationship and Team Management: Oversee the company’s relationship with External Partners and lead the Focus Factory Team, promoting collaboration among cross-functional members from Supply Chain, Quality, Technical Operations, and Procurement while championing diversity and inclusion. Strategic Planning and Compliance: Develop and align annual relationship priorities with company strategy, ensuring compliance with quality standards like Quality Risk Management and Change Control while driving operational excellence in production planning and resource management. Risk Assessment and Resolution: Proactively assess risks across the value chain, managing disputes and technology issues, and ensuring effective oversight of shop floor operations to mitigate risks and maintain quality and safety standards. Performance Monitoring and Improvement: Conduct site evaluations through GEMBA walks, lead Continuous Improvement and Lean Six Sigma initiatives, and prepare annual performance reports that summarize successes and lessons learned in external relationships. Collaboration on Commercial Aspects: Engage with External Manufacturing Procurement, Quality, and Technology on partner selection, contract negotiations, and capacity assessments to ensure alignment with operational needs and improvement strategies. Inventory and Agreement Management: Maintain the integrity of the Master Supply Agreement and oversee inventory control, documentation, and material disposition while supporting strategic initiatives and contributing to the development of the External Manufacturing Organization Handbook. What You Bring Educational and Professional Qualifications: Bachelor’s degree in Engineering and/or Science, with a minimum of 5 years’ experience in commercial/business and manufacturing roles (operations, quality, technology, planning), including at least 3 years of operational experience in a manufacturing environment (ideally in Active Pharmaceuticals or equivalent), with a focus on Execution Excellence. Proven ability to achieve compliance goals through a risk-based approach, with a deep understanding of Good Manufacturing Practices (GMP), Environmental Health and Safety (EHS) compliance, and quality compliance risks; direct experience with Health Authority audits is desirable. Demonstrated Lean Six Sigma capabilities to deliver compliant supply while achieving the highest quality, lowest cost, and shortest lead times, along with strong business and financial acumen to inform strategic business decisions. Proven management-level expertise in manufacturing modalities (API, Drug Product, Sterile) and the ability to visualize and identify strategic opportunities that add value and mitigate risks across the value chain. Excellent interpersonal, communication, collaboration, and negotiation skills for effective cross-boundary work. Willingness to travel 25% to 50% for new product introductions, including potential shift and weekend work as needed. Why Join Us? As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 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 make an impact in manufacturing please apply today. 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: Flexible Work Arrangements : Remote Shift Valid Driving License: Hazardous Material(s) Job Posting End Date: 04/8/2025 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. Requisition ID: R324820 #J-18808-Ljbffr
Job Description A fantastic opportunity has arisen for a CMMS Administrator. The CMMS Administrator is responsible for the management, maintenance, and optimisation of the Computerized Maintenance Management System (CMMS). This role involves implementing changes to the CMMS, ensuring data integrity, providing training and user support, and facilitating the effective use of the CMMS to enhance operational efficiency. Bring Energy, Knowledge, Innovation To Carry Out The Following CMMS Management: Administer and maintain the CMMS. Utilise ECM (engineering change management) process on SAP for control of changes to data. Gatekeep change requests to ensure data quality and GxP compliance. Responsible for the Site Operating Procedures (SOPs) for the CMMS. Act as CMMS subject matter expert during regulatory inspection. Analyze data for trends and insights to support decision-making and continuous improvement efforts in maintenance processes. Establish and promote best practices for maintenance management and CMMS usage among team members. Training and Support: Develop and deliver training programs for users to ensure effective use of the CMMS. Supports departmental shutdown meetings. Attends site daily shutdown meetings ensuring department owned activities are tracked and completed. What Skills You Will Need In order to excel in this role, you will more than likely have: 7 years of relevant academic and/or practical work experience in manufacturing, operations, or supply chain. A deep understanding of the technical and business processes in relation to a CMMS (Computer Maintenance Management System) and/or CCMS (Computer Calibration Management System). Familiarity with regulatory requirements in accordance with GMP manufacturing operations. Good oral and written communication skills. Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools. As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 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. 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: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 03/31/2025 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. Requisition ID: R341586 #J-18808-Ljbffr
Job Description The Biologics Analytical Research & Development department in Dunboyne has an exciting opportunity for an Associate Director (Biochem) . The Associate Director is a hybrid scientific/managerial role tasked with working closely with the group Director to define group strategy and to lead a team of scientists responsible for GMP biochemical assays. The remit of the group includes not only oversight of the execution of GMP release and stability activities, but also oversight of analytical method transfer/validation from development labs, oversight of method transfers to commercialization sites and support of regulatory filings. Our site in Dunboyne serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong, but that the facility belongs to and is shaped by them. We are looking for a team player with strong leadership skills and ability and passion for mentoring and managing scientists in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is beneficial. Your profile Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 4 years of experience in the pharmaceutical industry, M.Sc. in analytical chemistry/biochemistry or related field with a minimum of 7 years of experience in the pharmaceutical industry, or B.S. or equivalent in analytical chemistry/biochemistry or related field with a minimum of 10 years of experience in the pharmaceutical industry. Demonstrated ability to develop talent through good mentoring skills. Demonstrated ability for taking initiative, creativity and innovation in problem solving. Productivity and efficiency working in GMP laboratories. Thorough understanding of GMP policies and procedures and proven experience working with Quality. Subject matter expertise in Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis or other large molecule characterization technique. Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Proven experience in a leadership role with technical transfer experience in the biotech sector in any/all the following: Clinical Supply, Registration & Commercial Launch. Broad experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Mass Spectrometry techniques). Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics. Proven ability to develop and implement business related strategy to ensure continued & optimal team performance, realizing potential efficiencies. 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. #J-18808-Ljbffr
Job Description The Manufacturing BioTech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement. What You Will Do Bring your energy, knowledge, and innovation to: The production of biologic drug substance on their designated shift team and will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing. Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS standards and driving to optimise and improve the processing activities through use of standard work and lean processing techniques. Focusing on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers. What skills you will need: A science qualification in a technical, engineering or science-based discipline or equivalent. 1 to 3 years’ experience in the biotechnology industry or equivalent. Experience in a highly regulated pharmaceutical manufacturing environment. Good understanding in the production of biologic drug substance and experience an advantage. Ability to work as part of a shift team and on own initiative in a constructive manner. Ability to think logically and be proactive under pressure. Flexible and self-motivated. 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. Current Employees apply HERE Current Contingent Workers apply HERE Employee Status Regular Job Posting End Date: 04/10/2025 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. Requisition ID: R342219 #J-18808-Ljbffr
Job Description An amazing opportunity has arisen for a MS&T Bioprocess Engineer within the Validation Function. This position will be part of the MS&T Hub at our new State of the Art single use Multiproduct Biotech facility at site. What You Will Do Bring energy, knowledge, innovation and leadership to carry out the following: Participation in key technology transfers activities, in support of clinical and commercial new product introduction projects for cleaning and process validation. Support development of strategies for and the execution of process and clean validation programs. Acting as process Subject Matter Expert in the support of process investigations. Identification of innovation opportunities, support process optimisation projects including yield improvement or cycle time. Use of risk management techniques to assess strategies, prioritize activities and initiatives. Lead other significant projects on site and play a key role in the coaching and development of members of the MS&T and Manufacturing teams. Interact in single use materials within the validation function. What Skills You Will Need In order to excel in this role, you will more than likely have: Minimum of a Bachelor’s Level 8 degree in a technical field (e.g. Engineering, Science or equivalent) with multiple experience in the biotechnology or pharmaceutical industry. Technical understanding of biological drug substance upstream and/or downstream purification unit operations. Experience in clinical or commercial technology transfer activities desired. Process validation and cleaning validation experience desired. Ability to manage multiple priorities and knowing when to escalate for resolution. Flexible and self-motivated, with proven ability working cross functionally delivering technical solutions to issues. As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 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. Employee Status : Regular Relocation : Not specified VISA Sponsorship : Not specified Travel Requirements : Not specified Flexible Work Arrangements : Hybrid Shift : Not specified Valid Driving License : Not specified Hazardous Material(s) : Not specified Job Posting End Date : 04/8/2025 Requisition ID : R341067 #J-18808-Ljbffr
An amazing opportunity has arisen for a Senior Specialist Microbiology Virology in our Micro Analytical Sciences team. This team scientifically supports the microbiological laboratories in the commercial production sites for vaccines, biologics, and small molecules. The team plays a crucial role in supporting the transfer, troubleshooting, and life cycle management of the microbiological test methods (including equipment) for all modalities. This includes compendial test methods, non-compendial test methods, and alternative microbiological methods. Bring Energy, Knowledge, Innovation To Carry Out The Following The individual is responsible for several microbiological/virological methods and will act for some as a Subject Matter Expert (SME). The individual will have an important role in supporting the transfer of microbiological/virological methods for commercialized products, regulatory interaction such as response to questions and provide training to the network. The responsibilities encompass ensuring the proper introduction and qualification of methods by the receiving unit (including Dunboyne site) during the transfer process in accordance with applicable guidelines, as well as overseeing more complex products globally and facilitating the involvement of appropriate Subject Matter Experts at the appropriate time. The Senior Specialist will also support as an SME the evaluation, method development, method validation of alternative microbiological technologies (Rapid Microbiology Methods). On an as-needed basis, the Specialist provides practical and scientific support for alternative microbiological technology (Rapid Microbiology Methods), microbiological studies, and investigations supporting the Dunboyne site and/or network sites. This means that the SME offers both technical and scientific expertise during these processes and travels as required for at least 20% of their time. In addition to their responsibilities, the Senior Specialist can also serve as the point of contact for commercial production sites on microbiological methods and will act as a global method owner. The Senior Specialist will support the Micro Analytical Sciences Lead Dunboyne by coaching Specialist and Associate Specialist in the team and taking up a senior role in the team. What Skills You Will Need Minimum of Level 8 Bachelors degree, a masters is desirable or equivalent through experience. Minimum of 8 years relevant experience in preferably Pharmaceutical Microbiology/Virology. Strong project management skills & proven ability to manage complex projects. Proficient networker in global multidisciplinary teams. Broad knowledge of manufacturing, analytical development, and validation processes and microbiology/virology. Demonstrated initiative, and innovative process-oriented thinking within a team environment. Ability to lead and coach others to solve problems and take new perspectives on existing solutions. Demonstrated experience of technical leadership. Ability to think logically and be proactive under pressure. Knowledge of regulatory and quality guidelines (GMP). Strong focus on quality, safety, and compliance. Excellent analytical and technical skills. Preferably broad knowledge of manufacturing, analytical development, and validation processes and Microbiology/Virology. As a company, we are committed to 'Inventing for Life' in all that we do. 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 or click on the link to find out more about our hybrid working model. So, If You Are Ready To Invent solutions to meet unmet healthcare needs, please apply today. #J-18808-Ljbffr
An exciting opportunity has arisen for an experienced Qualified Person to join our Quality department at our Biologics facility in Dunboyne, Co. Meath. Our facility 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. What You Will Do Bring energy, knowledge, innovation, and leadership to carry out the following: Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures. Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement. Manage and/or escalate any potential CGMP and/or other concerns in a timely manner. Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material. Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed. Provide oversight ensuring all manufacturing, testing, and shipping processes remain in the validated state. Review and approve the Annual Product Review for the drug substance and ensure that all variations, deviations, change controls and CAPA’s are included for the period under review. Support supplier/material qualification and quality agreements review and approval as required. Support customer and supplier complaint process as required. Support Quality Risk Management processes as required. Support Market Action Response Team as appropriate in batch / product recalls. Ensure and promote compliance to regulatory requirements, evaluating site compliance against emerging regulatory trends and proactively engaging with global regulatory agencies when required. Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits. In order to excel in this role, you will have: Expert level of knowledge of relevant GMPs, regulations and current industry trends. Communication, decision making, people influencing and project management skills. Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues. Knowledge, experience, and leadership style to lead the site through the planning, strategy build and execution to ensure RFT regulatory approval. BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline. Proven track record in delivering operational excellence. EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures. Experience in the biotech industry is required with specific experience in audit readiness, regulatory agency engagement and ability to gain alignment on strategy with senior leadership. As a company, we are committed to 'Inventing for Life' in all that we do. 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. So, If You Are Ready To Invent solutions to meet unmet healthcare needs, please apply today. Current Employees apply HERE Current Contingent Workers apply HERE 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 03/30/2025 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. Requisition ID: R317637 #J-18808-Ljbffr
An exciting opportunity has arisen for a Manufacturing Learning Specialist for our Biologics Innovation hub in Dunboyne, Co. Meath. The successful applicant will develop and deliver a new MFG onboarding program and will be accountable for optimizing the training program to meet site needs. Key Responsibilities Will Include The person will ensure new hires are trained effectively with particular focus on their first 4 weeks onsite as new person onboards and ensuring time to competency is achieved. The role involves collaborating with other teams in support of delivering the BTA onboarding program. Leverage lab alternative site locations (internal and network) space to enable fast-track training of BTA’s. You will be responsible for delivering the onboarding program for new Manufacturing, including both classroom and competency-based training, and therefore the person should have expertise in delivering training and ensuring excellent knowledge transfer. The person should be confident to work with new technologies to improve training content and knowledge transfer e.g. GATE and XR. Responsible for ensuring time to competency is achieved. Monitor learning KPI’s and ensure all targets are being met, with the capability to determine if targets are aligned with changing site priorities. The person will work collaboratively with the Learning and Development Team and any other teams that can bring improved outcomes for learning. Determine and present progress and key learning metrics to team members and senior leaders. Working with the site-based shift teams to enhance training outcomes. Your Profile Excellent communication skills and be familiar with reading out on progress against a schedule (planned versus actual). Degree qualification (Science, Engineering). Minimum of 4 years’ experience in the pharmaceutical industry (preferably Drug Substance). Must be able to work in a fast-paced environment. Must have a working knowledge of training techniques. Have a proven track record in delivering both classroom and on-the-job training. Be familiar with learning plans and training metrics. Must have working knowledge of learning management systems and skill matrices. 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. 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. 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: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 03/28/2025 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. Requisition ID: R338167 #J-18808-Ljbffr
Job Description An amazing opportunity has arisen for an Operations Production Specialist (Shift role) to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland. This is a shift role. Our facility in Dunboyne, Co. Meath 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. Our Dunboyne facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. Our Dunboyne facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them. What You Will Do Bring your energy, knowledge, and innovation to: Lead/Guide team members within the Production Operations team. Coach and develop colleagues within the Production team. Provide designee cover in the absence of the Production Manager. Lead, facilitate and participate daily on cross-functional teams to collaboratively cover compliance topics. Operate equipment according to electronic batch records, sampling plans and standard operating procedures. Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working. Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups. Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation). Conduct all work activities with a strict adherence to the safety and compliance culture on site. Support the Authoring of electronic batch records, sampling plans, and standard operating procedures. Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs/WI’s. Required Education, Experience and Skills: Bachelor’s degree in biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. 4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate. Competent in analysing complex situations and show practical problem-solving capabilities. Ability to work independently and within a cross-functional team. Understanding of multi column chromatography concepts. Familiarity with contamination control and batch release requirements. Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits. Problem, Deviation, and Change Management experience. Preferred Experience and Skills: Commissioning and Qualification experience. Understanding of Upstream and Downstream Unit Operations for mAb manufacturing. Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process. Reports to: Drug Substance Process Operations Manager Employee Status: Regular Job Posting End Date: 04/30/2025 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. Requisition ID: R338780 #J-18808-Ljbffr
