Amgen Jobshttp://www.amgen.jobs2012-05-26 16:30:16.910423IRLDun LaoghaireAuto req 15464BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Job Description Position Title: QA Snr Associate Reports to: QP Group/Division: Amgen Dun Laoghaire Department: QA Shift Yes 24/5 Position Summary: This job specification outlines the general responsibilities associated with the role of QA Snr Associate at ADL. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role. The QA Snr Associates duties are as follows; • Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses. • Review and approve Master Batch Records • Review non conformances for completeness • Prepare the agenda for Site Quality Review Team and submits non conformances for review/discussion. • Prepares the SQRT minutes. • Assigns expiry date to products. • Prepare deviation trend reports bi annually to establish any evident trends. • Schedules products to be placed on the stability program • Status changes and yields product on the computer system • Prepares non conformance reports for shipments as required • Tracks CAPA’s detailed in non conformance reports • Writes, reviews and approves Standard Operating Procedures in accordance with Amgen Policies • Prepares Monthly Metrics. • Ensure compliance with Amgen procedures • Performs Quality Audits to ensure compliance with cGMPs • Maintains databases and other informational systems as necessary. • Prepares the KPI reports as required. • Complies with responsibilities as outlined in the site Safety Statement section 3.6. • Performs all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures. • Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans. • Is a champion for safe working practices and safety initiatives within their functional area. Basic Qualifications Education: Third level qualification, preferably to degree level, in a Science discipline. Experience: Minimum three years industrial experience or equivalent Preferred Qualifications Knowledge and training in QMTS, SAP, EBR and Maximo Strong organizational skills and ability to manage multiple tasks at one time Ability to follow assignments through to completion and meet timelines Self motivated Strong communication skills (both written and verbal) Demonstrated ability to work as both a team player and independently Ability to evaluate documentation and operations according to company procedures Ability to make decisions independently or elevate to management, as appropriate in an environment that balances business need, quality and compliance risk Strong word processing, database and spreadsheet application skills2012-05-17 20:58:26IrelandAmgenNone15464BRNoneDun Laoghaire, IRL28771078http://www.amgen.jobs/xml/28771078/jobIRLDun LaoghaireAuto req 15363BR Job Posting Title Mgr Maintenance Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Maintenance Manager – Level 5 Amgen Dun Laoghaire - Dublin This role leads a small group of engineers / technical professionals delivering a technical service requiring the job holder to apply knowledge and experience of engineering principles to a broad variety of assignments. Principally the jobholder will develop technical solutions to complex problems, while managing, coordinating and reviewing the work of others. •Carry out fault investigation and problem analysis for maintenance related issues, identify alternative solutions, prepare proposals for modifications or improvements and execute/trial as necessary •Provide input at various project stages to review maintainability – be involved in new equipment installation and accept handover from project teams to maintenance. Check technical content of handover documentation and ensure PM system is updated. •Administer control and develop PM System, provide technical input for developing PM’s and for other maintenance aspects of maintenance documentation; assisting with equipment/process fault identification and improvements. •Administer and control planned maintenance systems ensuring work orders are issued, completed and returned on time, running reports, analysing trends and issuing proactive worksheets. •Provide technical input into preparation and issue of SOP’s; corrective action tracking; operation and maintenance manuals. •Assist with preparation and co-ordination of shutdown activities, manage and review activity schedules and produce summary reports •Conduct area self assessment and implement corrective actions, evaluate new equipment/processes for safety issues related to maintenance functions. Conduct departmental risk assessment in conjunction with the EHS department. •Participation in ‘call-out system’ to cover Engineering response (out of normal hours, management of weekend maintenance activities Basic Qualifications •Bachelor's degree in Engineering, Science or related field. •Significant relevant work experience within operations/manufacturing environment •Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) •Established expertise in multiple areas of engineering technology. Preferred Qualifications •Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope. •Working knowledge of financial analysis tools' and appreciation for project cost development •Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation. •Written communication including technical writing. •Team leadership skills: Management, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-04-27 20:21:28IrelandAmgenNone15363BRNoneDun Laoghaire, IRL28241185http://www.amgen.jobs/xml/28241185/jobIRLDun LaoghaireAuto req 14194BR Job Posting Title Training and Development Manager Career Category Training Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description The Training and Development Manager will be responsible for developing partnerships with key clients while influencing and establishing operating standards and practices. To be successful in this role you will need to complete the following: • Under minimal supervision, partners with the client to apply human performance theory and needs analysis skills to analyze performance issues and identify solutions that support business needs. • When a training need is identified, can utilize instructional design and adult learning methodologies to design and develop solutions in a variety of delivery formats. • Manages assigned projects. • Works with internal clients to manage their curricula and assignments and ensure all training materials are integrated with Amgen’s learning management system per defined business processes. • Supports the gathering and evaluation of metrics that ensure the effectiveness of performance solutions and training materials. • Serves as an internal client’s first point of contact for performance and training questions. • Leads global training forum for client function and represents client during Operations global governance and prioritization processes. • Writes instructional materials, leader’s guides, etc, and able to modify existing material. • Develops and conducts Train-the-Trainer classes/support as needed. • Works with audit response teams to ensure appropriate actions are taken. • Provides proactive strategic planning to client regarding future performance needs and global curricula projects. • Serves on sustainment steering committee for applicable global programs. • Ensures that training content is current and reflects all technical and compliance standards. Basic Qualifications • Bachelors Degree or comparable professional experience in Instructional Design, Human Performance Technology, Life Sciences, or Business • 5+ years experience as a performance consultant, instructional designer, and/or curriculum developer • Knowledge of adult learning theory, instructional design, performance consulting, and needs analysis • Experience using ADDIE or other instructional design methodology in the creation of training materials • Experience supporting and/or creating materials for on-the-job training • 2+ year project management (managing projects, defining scope, overseeing budget, tracking milestones) • Travel, up to 10% Preferred Qualifications • 2 years experience in Microsoft Word, PowerPoint, and Excel • Any experience with business processes surrounding the use of learning management or training systems (i.e., SumTotal, ISOtrain) • Experience working in a regulated environment (FDA, OSHA, NRC, etc.) • 1 year experience with Visio and MS Project • eLearning design experience and knowledge of online performance support tools • Ability to work with staff across all levels of an organization • Effective communication and writing skills2012-03-21 18:36:06IrelandAmgenNone14194BRNoneDun Laoghaire, IRL27297538http://www.amgen.jobs/xml/27297538/jobIRLDun LaoghaireAuto req 14198BR Job Posting Title Sr Associate Training & Development Career Category Training Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Under limited supervision, delivers training programs to support business needs. Performs on-the-job training demonstrations and coaching sessions in a learning lab or actual production environment. Conducts classroom training. Works closely with assigned client groups to assess and meet training needs. FUNCTIONS • Responsible for effective delivery of training to client group. Includes classroom, one-on-one, and on-the-job training. Could also ensure effective delivery of eLearning courses. • Works closely with assigned clients, in their work environment, to understand and assess specific training needs. • Communicates client training needs to local training management. • Responsible for delivery of solutions to meet the specific training needs of assigned clients. • Responsible for effective delivery of cGMP and other regulatory training, as required by client group. • Delivers initial and ongoing training for new hires and transfers. Facilitates transition of new hires/transfer-ins from training environment to work environment. • Facilitates the assignment and un-assignment of training courses/modules for staff members. • Provides guidance to client on compliance and regulatory issues. • Participates and /or leads inspections activities. • Coaches and develops SME/ certified trainers within client area to be effective trainers. • Assists in review of human error”-related incidents: determine need for additional or modified training interventions for affected staff. • May provide input into the implementation of corporate core curricula and standard learning processes. • May participate on global training teams as assigned. • May include small scale training design projects to meet local client needs. Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of of experience directly related to the job OR Associate’s degree & 6 years of experience directly related to the job. Preferred Qualifications • Strong customer service orientation and influencing skills to work directly with client staff and identifying performance needs. • Working knowledge on computer software programs including: Word, Excel, and Power Point. • Works directly with client in delivering training. • Demonstrates understanding of Amgen’s business and culture, and ability to work effectively with staff at all levels • Technical competency commensurate with assigned area(s) of responsibility • Regulatory compliance competency commensurate with assigned area(s) of responsibility Skilled in process modeling and troubleshooting • Basic project management skills • Good interpersonal, group facilitation and presentation skills • Able to accomplish results through own work and through influencing client staff members and management2012-03-21 18:35:48IrelandAmgenNone14198BRNoneDun Laoghaire, IRL27297532http://www.amgen.jobs/xml/27297532/jobIRLDun LaoghaireAuto req 14036BR Job Posting Title Sr Mgr Manufacturing - Maintenance Packaging Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing – Maintenance Packaging Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing & Operations – Packaging. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations – Packaging area. Previous experience with maintaining packaging line equipment is a distinct advantage. Working knowledge of equipment from various vendors would also be advantageous. Key Responsibilities: • Manage the Maintenance of the all the Packaging Equipment within the syringe facility while ensuring Manufacturing smooth and consistent running of all equipment in the Packaging facility which has isolator technology. • Strong operating knowledge of pharmaceutical GMP’s and their application to the maintenance function. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. • Develop improvement strategies across the Maintenance function. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department. • Assure the appropriate level of training is undertaken for all levels of the Maintenance organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into Maintenance and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff. • Bachelor’s Degree or combination of education and/or years of experience. • Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable. Preferred Qualifications Preferred Qualifications# • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-03 20:26:16IrelandAmgenNone14036BRNoneDun Laoghaire, IRL26910351http://www.amgen.jobs/xml/26910351/jobIRLDun LaoghaireAuto req 14027BR Job Posting Title Director Manufacturing - Operations & Packaging Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Director Manufacturing – Operations & Packaging Amgen Dun Laoghaire - Dublin Overview: This role will report into the Executive Director Manufacturing and will be responsible for the management of the packaging manufacturing operations, over 4 lines and 2 work centres, at Amgen Dun Laoghaire. The successful Candidate will be responsible for maintenance of the facility, building of the packaging organisation and ensuring the on time delivery of GMP product in a safe and cost effective manner. Key Responsibilities: • Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage. • Ensure that the Manufacturing – Operations & Packaging area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department. • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture. • A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage. • Develop and maintain an effective organisation through selection, teaching, leadership and development Management. • Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities. • Experience of operations with both high mix and high volume, plus experience with different equipment manufacturers and packaging configurations. • Detailed experience relating to line integration. • The ability to specify the appropriate levels of automation to optimize line efficiency and output quality. • Experience with eliminating glass defects in vials and syringes during packaging operations. • Experience with packaging facility start up and tech transfer programs between different facilities. • Ensure effective two-way communication within the plant, with peers and groups internally and externally. • The ability to adopt a hand’s on approach during start up and commissioning phase. • The capability to undertake significant travel for vendor visits and FAT’s. • Responsibility for maintaining Amgen’s performance management system within the packaging area. Basic Qualifications Basic Qualifications: • Degree in Engineering or Science, with a background in manufacturing, quality, process development. • 10-15 years experience in managing significant packaging operations in a GMP environment. • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs. Preferred Qualifications Preferred Qualifications: • BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD) • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects • Strong technical skills related to scale up • Thorough knowledge of GMP biotechnology manufacturing • Solid understanding and knowledge of cGMPs • Awareness and understanding of quality and regulatory industry trends, policies and guidelines • Proven track record of advancement in an established, high performing organization • Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs • Excellent project management skills with the ability to lead effectively in an highly matrixed organization • Excellent communication skills able to work with and influence executive management • Strong understanding of validation of biopharmaceutical facilities, equipment and process • Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately2012-03-03 20:25:43IrelandAmgenNone14027BRNoneDun Laoghaire, IRL26910344http://www.amgen.jobs/xml/26910344/jobIRLDun LaoghaireAuto req 14041BR Job Posting Title Sr Mgr Manufacturing - Maintenance Syringe Career Category Maintenance Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Sr. Manager Manufacturing – Maintenance Syringe Amgen Dun Laoghaire - Dublin Overview: This position will report to the Director of Manufacturing & Operations – Syringe. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations – Syringe area. Previous experience in maintaining syringe manufacturing and inspection equipment is a distinct advantage. Experience with the use and maintenance of isolator equipment would also be advantageous. Key Responsibilities: • Manage the smooth and consistent running of all equipment in the Syringe facility which has isolator technology. • Strong operating knowledge of pharmaceutical GMP’s and their application to the maintenance function. • Lead in the development of Manufacturing’s vision, mission, strategies, goals and objectives to ensure the area achieves the company goals. • Responsible for ensuring that all maintenance is carried out under GMP conditions and in a safe working environment. • Support the plant in the project approval, prioritization, and implementation process. • Develop metrics to support the benchmarking of site, global, and industry. • Develop improvement strategies across the Maintenance function. • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by the Maintenance department. • Assure the appropriate level of training is undertaken for all levels of the Maintenance- Syringe organization which may involve developing training material. • Responsible for attaining and improving site based metrics targets. • Responsible for recruiting talented staff into Maintenance – Syringe and setting standards for their performance. • This position will need to complete some travel to the other Amgen sites over the next two years. * Other functions may be assigned. Basic Qualifications Basic Qualifications • Typically 8+ years of experience in facilities Maintenance position. With typically 4+ years experience supervising technical staff. • Bachelor’s Degree or combination of education and/or years of experience. • Ideally previous experience working within the Pharmaceutical, and/or manufacturing industries would be highly desirable. Preferred Qualifications Preferred Qualifications# • Knowledge of conflict resolution • Ability to partner with other departments. • Analytical problem solving. • Considerable Organization skills. • Experience in coaching, mentoring and counselling. • Ability to deal with and manage change. • Ability to set goals. • Knowledge of applicable regulatory guidelines • Ability to use company compensation system including mentoring lower management levels when required. • Team leadership skills: Supervision, delegation, coaching and mentoring, conflict resolution across permanent and contract staff.2012-03-03 20:25:23IrelandAmgenNone14041BRNoneDun Laoghaire, IRL26910341http://www.amgen.jobs/xml/26910341/jobIRLDun LaoghaireAuto req 14028BR Job Posting Title Dir Manufacturing - Syringe Career Category Manufacturing Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Director Manufacturing - Syringe Amgen Dun Laoghaire - Dublin Overview: This role will report into the Executive Director Manufacturing and will be responsible for the manufacturing of syringes at the Amgen Dun Laoghaire Site. The successful candidate will be responsible for the maintenance of the facility and for building an organization that ensures on time delivery of GMP product in a safe and cost effective manner. Key Responsibilities: • Excellent people skills allied to a strong leadership style, with a background in the biotech industry an advantage. • Ensure that the Manufacturing – Syringe area is staffed with motivated and well trained colleagues and that ongoing programmes are initiated and maintained to ensure flexibility and productivity within the department. • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture. • A detailed understanding of the regulatory requirements across different geographies and an extensive knowledge of same would be an advantage. • Develop and maintain an effective organisation through selection, teaching, leadership and development Management. • Define and regularly update our policies for all manufacturing, reflecting prior performance and current needs of the business. Liaise with the relevant supervisors in the course of the day to day activities. • Experience with syringe facility start up and tech transfer programs between different facilities. • Experience of syringe inspection operations with previous experience of training of staff in this area an advantage. • Detailed experience relating to all aspects of line integration. • A detailed understanding of the automation requirements necessary to optimize line efficiency and output quality. • Experience with eliminating glass defects in syringes during filling and inspection operations. • Prepares and submit annual expenditure budgets and monitor actual performance against these budgets, taking corrective action where necessary • Ensure effective two-way communication within the plant, with peers and groups internally and externally. • The ability to adopt a hand’s on approach during start up and commissioning phase. • The capability to undertake significant travel for vendor visits and FAT’s. • Responsibility for maintaining Amgen’s performance management system within the syringe filling area. Basic Qualifications Basic Qualifications: • Degree educated with significant relevant experience • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs. Preferred Qualifications Preferred Qualifications: • BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD) • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects • Strong technical skills related to scale up • Thorough knowledge of GMP biotechnology manufacturing • Solid understanding and knowledge of cGMPs • Awareness and understanding of quality and regulatory industry trends, policies and guidelines • Proven track record of advancement in an established, high performing organization • Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs • Excellent project management skills with the ability to lead effectively in an highly matrixed organization • Excellent communication skills able to work with and influence executive management • Strong understanding of validation of biopharmaceutical facilities, equipment and process • Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately2012-03-03 20:24:47IrelandAmgenNone14028BRNoneDun Laoghaire, IRL26910336http://www.amgen.jobs/xml/26910336/job