253 specialist manufacturing jobs found

Career Category Manufacturing Job Description Specialist Manufacturing Overview: Reporting to the Sr Manager Deviations Manufacturing Support, this position will manage the manufacturing deviations for Amgen Dun Laoghaire (ADL). The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following: Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings. Clear and concise technical writing of complex investigations Drive improvements to the investigation process Present investigations to regulatory inspectors and internal auditors Clearly communicate investigation progress to impacted...

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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...

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION?   You’ve   worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience ,   and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over   10 million patients   worldwide. Come do your best   work   alongside other innovative, driven professionals in this meaningful role.   Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen   FleX   Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The   FleX   Batch facility will not only feature the best in-class drug substance...

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   lie   within them,   you’ll   thrive as part...

Career Category Quality 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. Be...

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 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...

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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...

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...

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...

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...

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 . The TAS is a critical...

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 . This territory...

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 . This territory includes:...