198 specialist manufacturing jobs found

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....

In this role you will be responsible for providing QA oversight and support to manufacturing activities.  Performs and leads activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The successful candidate will be required to work shift which includes a mix of days & nights As a QA Specialist a typical shift might include, but is not limited to, the following: Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including:  Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations, Perform area walkthroughs, Provide oversight and...

Career Category Manufacturing Job Description Description: Flexible Commuter Must have skills: Project management. Technical writing. Understanding of Good Manufacturing Practices in the Biopharmaceutical, Pharmaceutical, or Medical Device industries. Experience or knowledge of operations (in the three industries listed above). Quality management skills including previous experience managing quality records in Trackwise, Veeva or a comparable quality system. Previous experience in inventory management systems such as SAP. Job Description: The Specialist, Manufacturing will serve as the primary point of contact and external supply quality record owner for Amgen’s sites in Ireland (Dun Laoghaire) and the Netherlands (Breda). The main responsibility of this role is to manage quality records for events associated with the Secondary Packaging and Device categories, while also providing support for events in additional categories as needed. This support includes...

Career Category Manufacturing Job Description Site Syringe Fill Finish Process Owner   Job Summary:   An exciting and rare opportunity has presented for a Site Fill Finish Process Lead at Amgen, Dublin. This is a senior role in the organisation and requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.    As a Fill Finish Process Lead you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to the manufacturing operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from a manufacturing operations perspective.    Supporting key areas of the business, the Fill Finish Process Lead will direct initiatives that improve the...

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

Career Category Supply Chain Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

Career Category Information Systems Job Description Role Description:   In this vital role you will partner with the EPD (External Planning & Delivery) Business Team to advance and automate day-to-day planning and procurement to accelerate strategy and growth. You will also help build long-term roadmaps for the Ariba Supply Chain Collaboration (SCC) and Sub-Con tracting modules to onboard Direct Suppliers and Contract Manufact ur ers ( CMO’s ) . Support designing and maintaining a vision for how technology can be leveraged to tackle critical business problems, understand the impact of technical solutions on business outcomes and ensure growing the value of investments made. You will collaborate and engage with various partners and help in delivering standard methodology solutions based on business requirements.   We value individuals who have high personal standards of productivity, quality, and ethics. We value people...

Within this role you will be responsible for tasks related to the support of manufacturing operations (Large Scale & Sub-Suites); primarily the tracking, collation , analysis and presentation of manufacturing operations data & metrics by liaising with all manufacturing functions and other departments to collate and track relevant data. As an Associate Manufacturing Operations Specialist, a typical day might include, but is not limited to, the following: Collating data/KPI metrics from multiple sources both internally & externally (including EHS, HR, QC Finance, QA) for manufacturing operations Compiling the data into charts, spreadsheets and scorecards or other as required Preparing presentations on the compiled data and presents this data; presents at relevant departmental meetings Responsible for the collation and upkeep of all trackers and spreadsheets in relation to headcount resources within manufacturing operations Participating in...

The Manufacturing Equipment Specialist p erforms tasks related to the set-up and start-up of manufacturing operations (Large Scale & Sub-Suites); primarily, the qualification of Manufacturing Small Equipment, review and approval of equipment qualification packages, purchase, delivery & installation of cleanroom furniture and storage, liaising with external vendors, lead / support projects relating to small equipment introduction and qualification. As a Manufacturing Equipment Specialist, a typical day may include, but is not limited to, the following:   Qualifying small equipment by liaising with multiple vendors, reviewing and signing off of qualification packages, completing BMRAM activities including ECN builds and PM event builds for multiple pieces of equipment Generating System Impact Assessments and System Requirement Specifications for new equipment and updating old equipment SRS/ SIA Defining standards, controls and...

Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data. As a Manufacturing MES Specialist a typical shift might include, but is not limited to, the following: Chair reviewing and approving sessions of MES project deliverables against the overall project plan MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs) Leading Pre-PE executions (Static and Dynamic) and testing of MES records Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME Coordinating team and documentation of all testing protocol and ensure GDP and compliance Coordinating of Workflows for documentation approval Reviewing of data for build of OPM...

Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data. This is an extended days position. As a Manufacturing MES Specialist a typical shift might include, but is not limited to, the following: Chair reviewing and approving sessions of MES project deliverables against the overall project plan MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs) Leading Pre-PE executions (Static and Dynamic) and testing of MES records Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME Coordinating team and documentation of all testing protocol and ensure GDP and compliance Coordinating of Workflows for documentation approval...

The QA Specialist/Sr QA Specialist for External Drug Product Manufacture provides QA oversight to ensure that drug product manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. A typical day might include, but is not limited to, the following:   Reviewing and approving the following document types, relating to area functions: Master records, Executed records, Failure investigations, Change Control & Partner Notifications, Standard Operating Procedure (SOPs) Coordinating QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management Providing governance/performing compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Representing Quality Assurance both internal to Regeneron and External with Partners and Contract Manufacturers in...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

  At KARL STORZ, we are driven by a mission to enhance global health through innovative technology designed to tackle the most complex surgical procedures and medical challenges.    One of the most rewarding ways to launch your career with us is by joining our Onsite Endoscopic Specialist (OES) team. In this role, you will be at the forefront of healthcare innovation, providing hands-on support for KARL STORZ advanced medical devices—ranging from hand instruments to state-of-the-art video equipment—within your assigned hospital.    As an OES, you will collaborate closely with the Sterile Processing Departments and Operating Room teams, playing a critical role in ensuring the success of surgical procedures. This position is more than just a job—it is a gateway to an exciting and diverse career path. Whether you aspire to transition into medical device sales, advance into leadership, share your knowledge as an educator, or specialize in marketing, the opportunities for growth...

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary:...

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary: The...

The Opportunity: Join a company that tackles fascinating problems and find solutions to complex challenges. With expertise in influenza science and beyond, our team works on the latest research, pioneering technologies to improve the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organization drawing together expert staff from different countries to collaborate. Together, we are working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose to deliver our promise. This is a field-based management position for the North Central region.  Reporting to the Director of Sales, you will: Achieve the regional sales goals (volume and profitability) by managing a team of Influenza Vaccine Sales Specialists and accounts in multiple channels, including...

Career Category Quality Job Description Specialist – QA Technical Support NPI Live    What you will do    Let’s do this. Let’s change the world.  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 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.  The Quality Assurance Technical Support Specialist NPI (New Product Introduction) is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of...