A leading biotechnology company in Ireland is seeking a Sr. Project Equipment Engineer to support the expansion of production capabilities. The role involves project management, technical project execution, and compliance with Good Manufacturing Practices. Candidates should possess a Bachelor's degree in engineering and have at least 5 years of relevant experience. In addition, the position offers a competitive salary and comprehensive benefits package. #J-18808-Ljbffr
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally. As a member of the Technology Projects Team, the role will support complex and challenging system technology initiatives and project delivery. Key Responsibilities Responsible for supporting all tasks related to the technology system project lifecycle, from solution design to GMP qualification. Project management and execution of assigned projects including project prioritisation, resource management, status reporting and external communication. Working with various stakeholders to scope projects and ensure requirements are satisfied. Critically analysing system design, developing, and recommending continuous improvements in line with the latest technology and regulatory standards. Work in a collaborative manner within cross functional teams. Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs. Solving complex problems, lifecycle management and operational excellence. Develop and manage change control requests per established SOPs and processes. Develop detailed specifications, engineering documents, system impact assessments, test protocols and standard operating procedures. Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Travel at various times may be required to support execution of projects. Preferred Qualification And Experience Bachelor’s in electrical engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment. Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities. Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment. Experience programming and troubleshooting PLC (e.g. Allen Bradley, Siemens, B&R), SCADA (e.g. IFix, InTouch, Zenon), PCS (e.g. Rockwell Automation Platforms) and Batch Systems (e.g. Factory Talk Batch). Industrial Networking experience with ControlNet (CNET), DeviceNet, Profibus etc. Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk AssetCentre, ThinManager and OSIsoft PI Data Historian. Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11. Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls. Solid leadership, technical writing, and communication/presentation skills. Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Experience in developing technology strategies for new product introduction and new technology deployment. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans. Ability to influence the development of business area strategy and Technology strategy where appropriate. Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements. Independent, self-motivated, organised and able to multi-task in project environments. Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals. #J-18808-Ljbffr
Sr. Project Equipment Engineer – Amgen Amgen Dun Laoghaire (ADL) is looking for a Sr. Project / Equipment Engineer to join our facilities & engineering team to support the continued expansion of the plant and production capability on site. The engineer will report to the Associate Director for Facilities & Engineering and is responsible for portfolio ownership, scoping, and executing technical projects within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and Inspection areas. This includes new product introductions, qualification of new equipment and implementation of associated reliability and maintenance programs. Key Responsibilities Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion. Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up. Coordination of engineering readiness scoping and readiness for new product introductions. Project management and execution of assigned projects including prioritization, resources management, status management and external communication. Working with various stakeholders to scope projects and ensure requirements are satisfied across concept, design, construction, commissioning and commercial operational readiness. Development and implementation of maintenance programs and spare parts inventory optimization with introduction of new equipment. Translate strategic/emerging technology solutions into pragmatic executable plans. Development and management of change controls. Participate as a member of multidisciplinary site and multisite teams. Development of detailed specifications, engineering documents, protocols and standard operating procedures. Collaborate within the Process Teams structure and contribute to Root Cause Investigations and Cross Functional Investigations. Work with System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits. Ensure compliance with Good Manufacturing Practices and company requirements, policies and procedures. Support a safe working environment by complying with environmental health/safety practice, rules and regulations. Travel may be required to support execution of projects. What We Expect of You Bachelor’s degree in engineering (Mechanical, Electrical or Chemical) or relevant experience. Typically, 5+ years’ engineering experience, preferably in the biotechnology industry/aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes. Technology transfer experience preferred. Proven project management experience. Strong mechanical capability and hands on experience in a technical role within a high-volume manufacturing environment, advantageous. Demonstrated experience in a GDP compliant environment. Experience in MS Office, MS Project, Change Control & Document Management Systems. Proven ability working cross-functionally, delivering technical solutions and implementing improvements. Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results. Technical report writing and communication/presentation skills. Data-driven decision maker. Ability to work to tight deadlines in a fast-moving environment. What You Can Expect of Us In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. Amgen is an equal opportunities employer. Location: Dublin, County Dublin, Ireland #J-18808-Ljbffr
A leading biotechnology company in Dublin is looking for a professional to support technology systems project lifecycle. The role involves project management, stakeholder collaboration, and continuous improvement in automated systems for biopharmaceutical manufacturing. The ideal candidate will have a Bachelor's degree in Electrical Engineering, with extensive experience in operations and control systems automation. The position requires strong communication skills and a proactive approach to project execution. #J-18808-Ljbffr
A leading biotechnology company in Dublin is looking for a Technology Projects Team member to handle complex system technology initiatives. The candidate will support all aspects of the project lifecycle, manage resources, and ensure compliance with manufacturing standards. Ideal applicants have a Bachelor's degree in relevant engineering fields, along with over five years of experience in manufacturing automation within biopharmaceutical environments. Excellent communication skills and the ability to work collaboratively are essential. This role provides an opportunity to impact health outcomes significantly. #J-18808-Ljbffr
6 days ago Be among the first 25 applicants Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally. As a member of the Technology Projects Team, the role will support complex and challenging system Technology initiatives and project delivery. Key Responsibilities Responsible for supporting all tasks related to the technology system project lifecycle, from solution design to GMP qualification. Project management and execution of assigned projects including project prioritisation, resource management, status reporting and external communication. Working with various stakeholders to scope projects and ensure requirements are satisfied. Critically analysing system design, developing, and recommending continuous improvements in line with latest technology and regulatory standards. Work in a collaborative manner within cross functional teams. Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs. Solving complex problems, lifecycle management and operational excellence. Develop and manage change control requests per established SOPs and processes. Develop detailed specifications, engineering documents, system impact assessments, test protocols and standard operating procedures. Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Travel at various times may be required to support execution of projects. Preferred Qualification And Experience Bachelor’s in electrical engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment. Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities. Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment. Experience programming and troubleshooting PLC (e.g. Allen Bradley, Siemens, B&R), SCADA (e.g. IFix, InTouch, Zenon), PCS (e.g. Rockwell Automation Platforms) and Batch Systems (e.g. Factory Talk Batch). Industrial Networking experience with ControlNet (CNET), DeviceNet, Profibus etc. Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk AssetCentre, ThinManager and OSIsoft PI Data Historian. Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11. Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls. Solid leadership, technical writing, and communication/presentation skills. Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Experience in developing technology strategies for new product introduction and new technology deployment. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans. Ability to influence the development of business area strategy and Technology strategy where appropriate. Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements. Independent, self-motivated, organised and able to multi-task in project environments. Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals. #J-18808-Ljbffr
A global biotechnology company in Dún Laoghaire is looking for a Sr. Project / Equipment Engineer to lead technical projects and manage the introduction of new processes and equipment. The ideal candidate will have a Bachelor's degree in engineering, at least 5 years of experience in a biotech or pharmaceutical environment, and strong project management and problem-solving skills. This role offers a competitive salary, comprehensive benefits, and opportunities for career advancement. #J-18808-Ljbffr
Live What you will do Let's do this. Let's change the world. Amgen Dun Laoghaire (ADL) is looking for a Sr. Project / Equipment Engineer to join our facilities & engineering team to support the continued expansion of the plant and production capability on site. The Sr. Project / Equipment Engineer will report to the Associate Director for Facilities & Engineering and is responsible for portfolio ownership, scoping and executing technical projects within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and Inspection areas. This includes new product introductions, qualification of new equipment and implementation of associated reliability and maintenance programs. Key Responsibilities Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion. Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up. Coordination of engineering readiness scoping and readiness for new product introductions. Project management and execution of assigned projects including project prioritization, resources management, status management and external communication. Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and commercial operational readiness. Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment. Ability to translate strategic/emerging technology solutions into pragmatic executable plans. Development and management of change controls. Participate as a member of multidisciplinary site and multisite teams. Development of detailed specifications, engineering documents, protocols and standard operating procedures. Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations. Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits. Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures. Support a safe working environment by complying with environmental health/safety practice, rules and regulations. Travel may be required to support execution of projects. Win What we expect of you The successful candidate for this role will bring the following education, skills and experience Bachelor's degree in engineering (Mechanical, Electrical or Chemical) or Relevant Experience. Typically, 5+ years' engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes. Technology transfer experience preferred. Proven project management experience. Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous. Demonstrated experience in a GDP Compliant environment. Experience in MS Office, MS Project, Change Control & Document Management Systems. Proven ability working cross functionally, delivering technical solutions and implementing improvements. Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results. Technical report writing and communication/presentation skills. Data driven decision maker. Ability to work to tight deadlines in a fast-moving environment. Thrive What you can expect of us In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. Amgen is an equal opportunities employer To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register. #J-18808-Ljbffr
Associate Director Plant Quality Assurance Associate Director QA role at Amgen The Associate Director QA is a senior leadership role within Quality responsible for oversight of production operations and developing, implementing, and overseeing compliance programs and continuous improvement initiatives. The Associate Director will lead and direct Quality staff, act as a Subject Matter Expert in their area, and partner cross-functionally to embed a culture of quality, drive operational excellence, and support organizational growth. Responsibilities Lead and direct Quality staff, managing performance and supporting development of technical and decision-making skills. Provide QA oversight and support for production operations, including formulation, vial and syringe fill finish aseptic operations, and inspection operations. Collaborate with Operations & Engineering to resolve quality and compliance issues, including Change Controls, Deviations, and CAPAs. Represent Quality during audits and inspections. Support Lean Transformation and Operational Excellence initiatives. Basic Qualifications University degree in Engineering or Science related discipline. 10+ years of experience in pharmaceutical or biotechnology industry, with a minimum 3+ years in a leadership role, or an equivalent combination of experience and education. Technical skills and demonstrated competencies across a broad range of quality related disciplines. Experience working with dynamic cross-functional teams and proven decision-making abilities. Preferred Qualifications Experience in aseptic operations, protein formulation, vial and syringe filling. Knowledge of applicable regulatory requirements and experience with regulatory inspections. Excellent written and verbal communication skills. Seniority Level Not Applicable Employment Type Full-time Job Function Quality Assurance Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr
A leading biotechnology company in Dublin is seeking an Associate Director of Quality Assurance. In this senior leadership role, you will oversee production operations and ensure compliance, while guiding and developing a team within Quality. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and strong leadership skills. This position is full-time and offers opportunities to drive quality initiatives and operational excellence. #J-18808-Ljbffr
