A leading pharmaceutical company in Dublin is seeking a Senior Facilities Engineer to maintain the facility according to cGMP standards. The candidate will manage maintenance systems, support equipment procurement, and assist in the installation of production cells. A relevant engineering degree and significant manufacturing experience are required. This role offers opportunities for professional development within a collaborative team. #J-18808-Ljbffr
A global healthcare company in Dublin is seeking a Senior Associate in Regulatory Affairs to manage post-market surveillance for medical devices. The role requires extensive regulatory knowledge and collaboration with cross-functional teams. Candidates should have a Bachelor's degree and relevant regulatory experience, with strong communication skills. This position offers a chance to work in a dynamic environment with opportunities for development. #J-18808-Ljbffr
A global healthcare company seeks a Manager for Supply Planning to oversee end-to-end product supply across a worldwide manufacturing network. The ideal candidate will have 8-10 years of supply chain experience, strong leadership capabilities, and the ability to translate strategic plans into operational actions. This position plays a critical role in ensuring supply chain performance and involves collaboration with various functions including Commercial and Operations. #J-18808-Ljbffr
A leading pharmaceutical company in Dublin is seeking a technical project support professional to improve production quality and efficiency. This role requires at least 3 years of experience in the medical device industry and an Associate's Degree in Engineering. Responsibilities include developing project plans, ensuring compliance with technical requirements, and maintaining automation systems. This is a 12-month fixed term contract. #J-18808-Ljbffr
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work, and are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary Note: This is a 12-month fixed term contract. Responsibilities Support development of new technology, existing technology and existing production lines to improve quality, profitability and safety. Develop, execute and document project assignments in compliance with committed timelines and project goals, and per established governance policies and procedures. Ensure technical and customer requirements for assigned projects are achieved. Develop and maintain required validation and project management documents. Conduct or participate in routine project reviews with Project Teams and Management. Perform design work, layouts, sketches, concepts, etc. as needed for projects and/or plant layouts. Develop and/or review engineering change requests for modifications to processes, equipment and facilities. Troubleshoot and repair of all automation. Evaluate and maintain proper machine safeties to ensure employees are protected when operating any piece of automation. Ensure automation lines are meeting their targeted output and OEE by analyzing production data. Maintain quality finished product through proper maintenance and operation of all automation. Provide timely notification to shift leaders and program managers of maintenance and down time issues. Interfaces daily with engineering manager and shift support staff. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Performs other duties as assigned by management. Exhibits regular, reliable, punctual and predictable attendance. Automation includes – assembly machines/fixtures, label applicators, robots, end of arms, separators and test equipment. Any other equipment assigned by management. Education Associate's Degree In a relevant Engineering subject required. Bachelor's Degree In a relevant Engineering subject preferred. Work Experience Minimum 3 years Experience in medical device industry or other regulated industry required. Minimum 3 years Experience in supporting technical project management preferred. Preferred Knowledge, Skills And Abilities Background in medical devices/pharmaceutical would be a plus. Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and relevant ISO standards. Travel Requirements 5%: Up to 13 business days per year. Physical Requirements Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects. Additional Requirements Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may always be stressful due to competing resources while maintaining company confidentiality. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening. #J-18808-Ljbffr
A leading pharmaceutical company in Waterford is seeking a Supplier Quality professional. The role includes establishing supplier management plans and monitoring supplier performance to ensure compliance with quality standards. Candidates must have a Bachelor's in Engineering or Science, along with 5+ years of relevant experience. This hybrid position requires strong negotiation and problem-solving skills, with a commitment to quality excellence. #J-18808-Ljbffr
Manager, Laboratory Operations – West Pharmaceutical Services Job Summary In this role, you will be responsible to manage the daily business of routine testing. This includes providing direction, organization, and capacity planning of the release testing teams, global network support testing (product bags), preparation and reporting of Key Performance Indicators, setup of training processes in the lab team. Provide day‑to‑day support to the lab teams ensuring they are delivering to business needs. As part of the role, the position holder replaces the senior laboratory manager for assigned management tasks and during absence. Essential Duties and Responsibilities Manage the day‑to‑day business for routine testing (up to 4 individual teams) including capacity planning. Lead Tier 2 meetings, prepare and report lab statistics/KPIs to Tier 3. Manage the global lab network support testing (product bag release testing, support testing). Give technical support and guidance on quality processes to laboratory supervisors. First point of contact for requests regarding laboratory management from local or global positions. Mitigate critical backlog situations and escalate as necessary. Provide guidance on prioritization to the lab team based on input from site management. Responsible for training processes in the lab including training of new test supervisors. Approve laboratory management in quality processes, e.g. CAPA, Deviation, Laboratory Investigations, and ensure timely closure. Implementation of processes and procedures to ensure on‑time delivery of all testing in compliance with cGMP and regulatory guidelines/industry standards and local and global safety guidelines. Review and approve documents such as laboratory investigations, work instructions, SOPs, etc. Participate in cross‑functional teams as laboratory operations leads to provide input and consultation for laboratory testing and projects. Keep current with new technologies and cGMP regulations. May have people management responsibilities. Education Bachelor's Degree in Science with focus on Chemistry, Microbiology or related scientific area required. Work Experience Minimum 8 years of experience of management experience, GMP testing, analytical testing and instrumentation required. Preferred Knowledge, Skills and Abilities Ability to take initiative, work efficiently to meet deadlines, and work in a team environment. Able to work independently and remain self‑motivated with minimal direct supervision. Highly organized, thorough, and possess and practice good record‑keeping skills. Good communication skills. Service orientation. Technical understanding. Strong analytical and problem‑solving skills. Superior verbal/written skills. Good punctuation, spelling, grammar and attention to detail. Resilience and ability to work in a team. Continuous willingness to undergo further training. Independent way of working. Conforms with and abides by all regulations, policies, work procedures, instructions, and all safety and quality rules. Must function effectively in a diverse, cross‑functional team. Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description. Able to comply with the company’s safety policy at all times. Able to comply with the company’s quality policy at all times. Able to follow directions, prioritize tasks, and work independently. Must have excellent interpersonal, written and verbal communication skills. Must be proficient in Microsoft Office tools and capable to learn other software programs. Able to review regulatory code and learn safety standards. Occasionally come in earlier than their normal afternoon start time. Travel Requirements 5%: Up to 13 business days per year. Physical Requirements Light‑Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently to move objects. Additional Requirements Job‑related activities that require a physical activity such as standing in laboratory environment. Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms. Job‑related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures). What We Offer West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre‑employment drug screening. #J-18808-Ljbffr
A leading pharmaceutical company in County Waterford is seeking a Manager, Laboratory Operations. This role involves managing daily business operations of routine testing, providing direction to the testing teams, and ensuring compliance with regulatory guidelines. The ideal candidate will have at least 8 years of management experience in GMP testing, great communication skills, and a Bachelor's degree in a science-related field. Competitive compensation is offered. #J-18808-Ljbffr
Senior Specialist, Product Development, R&D Join to apply for the Senior Specialist, Product Development, R&D role at West Pharmaceutical Services . At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War II. Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. How will yours help write our future? Description There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary In this role, you will support design and development activities within West's Product Development Process demonstrating leadership and strategic thinking within a goal‑oriented organization. The incumbent will demonstrate accountability for the successful and timely achievement of goals, work independently only with strategic guidance in the most complex situations, interpret internal and external business issues and unmet needs, and take a broad perspective to define/plan/lead/develop solutions. You may collaborate with local and global functional groups, stakeholders, and management to deliver project goals and meet project milestones. Essential Duties And Responsibilities Plan and execute projects through all phases with a focus on design and qualification through verification and validation phases. Facilitate and lead the generation of requirements documentation, risk management documentation (e.g., user and product FMEA) in support of R&D projects. Create and edit product design models/drawings. Write engineering test protocols, reports, and work instructions. Plan, execute, and analyze design of experiments (DOE). Lead technical and design reviews. Drive innovation and process efficiency of integrated systems by applying innovative and logical risk‑based approach to product development challenges with the capacity for original thinking. Apply engineering principles for design/analysis of complex technical problems and develop solutions using sound principles, and utilizing experimental, computational, and analytical methods. Examine solutions based on functionality, quality and cost. Write, implement, and leads bench studies, tolerance stack up analysis, design verification, validation, materials specifications, and component specifications. Generate, record and analyze data, and present results to peers and business leadership. Point of contact for technical product related discussions with the team. May provide technical expertise and communication for internal and external partners. Integrate planning activities between West and development/manufacturing partners, and work closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process. May characterize system and/or sub‑system inputs, outputs and functionality, utilize analytical skills and develop simulation tools to define appropriate product specifications, and system reliability. May implement best practices for methodology, and attend and conduct necessary training for staff as methodology is established. Mentor and guide system engineers. Additional Responsibilities Leading new product ideation activities, concept development and evaluation. Applying design for manufacture principles to support high‑volume manufacturing processes. Education Bachelor’s Degree in Mechanical or Biomedical Engineering required; or equivalent experience Master’s Degree Mechanical or Biomedical Engineering preferred; or equivalent experience Work Experience Minimum 5 years experience in the medical device or combination product industry required Experience in high‑volume, automated manufacturing processes, and glass forming preferred Experience in Human Factors for Medical Devices preferred Expertise with test method development, validation strategy, and execution required Preferred Knowledge, Skills And Abilities Working knowledge of ISO 13485, 2017/745 (MDR) and 21 CFR Part 820 is essential Expertise with risk management, design verification and validation strategy development and execution Expertise in medical device design control and change management Experience with combination products requirements and regulation Proficiency in CAD solid modeling/drafting Proficiency in solid mechanics/mechanics of materials Proficiency in statistical methods/tools Proficiency in project management Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives Strong interpersonal and decision‑making skills and the ability to effectively manage change and uncertainty Knowledge of applicable ISO, and USP standards for drug delivery Knowledge of applicable health authority regulations including FDA, MDR Ability to comply with the company’s safety and quality policies at all times Travel Requirements 20%: Up to 52 business days per year Physical Requirements Sedentary – Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Additional Requirements Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time. Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures. Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities. Read and interpret data, information and documents. Must maintain the ability to work well with others in a variety of situations. Must be able to multi‑task, work under time constraints, problem solve, and prioritize. Ability to make independent and sound judgments. Observe and interpret situations, analyze and solve problems. Able to perform Research and Development lab activities. Must be able to deal with ambiguity, use timely decision making, understand sensitivity for IP protection, deliver concise presentations to high‑profile conferences, understand strategic direction, make contributions to strategy formation, be reliable and have predictable attendance. What We Offer This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. Shift Day shift: 8am – 5pm Hybrid role: 2 days wfh and 3 days on‑site West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post‑offer background screening and/or drug screening. #J-18808-Ljbffr
Social network you want to login/join with: Senior Associate, Regulatory Affairs, Dublin col-narrow-left Client: West Pharmaceutical Services Location: Dublin, Ireland Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: f09334ad4381 Job Views: 7 Posted: 17.08.2025 Expiry Date: 01.10.2025 col-wide Job Description: Job Summary The Senior Regulatory Affairs Specialist is expected to perform with input from management and is responsible for post-market activities for Administration and Safety System medical devices. The Senior Specialist will support department regulatory processes and procedures, supporting strategies for worldwide PMS activities. Responsible for supporting products/projects with regards to product Post Market activities, Adverse Event Reporting, and device risk management throughout various stages of design and development of Administration and Safety Systems. Maintain knowledge of current US, EU and international regulations/guidelines/policies related to medical devices as applicable to West’s products and services. Essential Duties and Responsibilities Complete global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in West’s portfolio. Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities. Responsible for complaint monitoring and adverse event reporting globally. Author with guidance to create PMS Plans, PMS Reports including Periodic safety update reports (PSUR), China NMPA Periodic Risk Evaluation Reports (PRER), Canada Summary Reports and other reports required by various health authorities along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF). Support the creation and streamline of processes to assure proactive surveillance (database searches, questionnaire) and reactive surveillance (complaints handling, field actions) is conducted accurately and efficiently. Collaborate with cross-functional team members in collecting, reviewing and analyzing and reporting on safety and performance data to identify potential adverse safety risks or performance trends. Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally. Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures. Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, SharePoint, MasterControl, Adobe, MS Teams, Outlook, and others as required. Adhere to all applicable regulations, practices, and procedures to maintain compliance. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all local site Environmental, Health and Safety regulations. Compliance to all local site company policies, procedures and corporate policies. Other duties as assigned. Education Bachelor's Degree in science, math, engineering, or related discipline required or Master's Degree in science, math, engineering, or related discipline or PhD in science, math, engineering, or related discipline Work Experience 5+ years (with bachelor’s degree) or 3+ years (with Master’s/PhD degree) of medical device regulatory experience. Preferred Knowledge, Skills and Abilities Advanced knowledge of global device adverse event/incident reporting requirements Attention to detail with planning, time management and organizational skills Minimum US Class II and EU Class IIa device experience Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) and ISO 14971 International regulatory competency Good oral communication and technical writing skills Experience with administration and safety systems preferred Self-motivated with a proactive attitude and the ability to work effectively Able to comply with the company’s safety policy at all times. Able to comply with the company’s quality policy at all times. License and Certifications Regulatory Affairs Certifications (RAC) preferred Additional Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Ability to comprehend principles of math, science, engineering, and medical device use. Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment. Travel Requirements 5%: Up to 13 business days per year Job Summary The Senior Regulatory Affairs Specialist is expected to perform with input from management and is responsible for post-market activities for Administration and Safety System medical devices. The Senior Specialist will support department regulatory processes and procedures, supporting strategies for worldwide PMS activities. Responsible for supporting products/projects with regards to product Post Market activities, Adverse Event Reporting, and device risk management throughout various stages of design and development of Administration and Safety Systems. Maintain knowledge of current US, EU and international regulations/guidelines/policies related to medical devices as applicable to West’s products and services. Essential Duties and Responsibilities Complete global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in West’s portfolio. Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities. Responsible for complaint monitoring and adverse event reporting globally. Author with guidance to create PMS Plans, PMS Reports including Periodic safety update reports (PSUR), China NMPA Periodic Risk Evaluation Reports (PRER), Canada Summary Reports and other reports required by various health authorities along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF). Support the creation and streamline of processes to assure proactive surveillance (database searches, questionnaire) and reactive surveillance (complaints handling, field actions) is conducted accurately and efficiently. Collaborate with cross-functional team members in collecting, reviewing and analyzing and reporting on safety and performance data to identify potential adverse safety risks or performance trends. Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally. Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures. Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, SharePoint, MasterControl, Adobe, MS Teams, Outlook, and others as required. Adhere to all applicable regulations, practices, and procedures to maintain compliance. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all local site Environmental, Health and Safety regulations. Compliance to all local site company policies, procedures and corporate policies. Other duties as assigned. Education Bachelor's Degree in science, math, engineering, or related discipline required or Master's Degree in science, math, engineering, or related discipline or PhD in science, math, engineering, or related discipline Work Experience 5+ years (with bachelor’s degree) or 3+ years (with Master’s/PhD degree) of medical device regulatory experience. Preferred Knowledge, Skills and Abilities Advanced knowledge of global device adverse event/incident reporting requirements Attention to detail with planning, time management and organizational skills Minimum US Class II and EU Class IIa device experience Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) and ISO 14971 International regulatory competency Good oral communication and technical writing skills Experience with administration and safety systems preferred Self-motivated with a proactive attitude and the ability to work effectively Able to comply with the company’s safety policy at all times. Able to comply with the company’s quality policy at all times. License and Certifications Regulatory Affairs Certifications (RAC) preferred Additional Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Ability to comprehend principles of math, science, engineering, and medical device use. Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment. Travel Requirements 5%: Up to 13 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. #J-18808-Ljbffr
