16 facilities jobs found

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...

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....

Within this role you will be responsible for providing technical support on the manufacturing process. You will be a key member in the implementation of large scale commercial manufacturing production program and heavily involved in the technical transfer of processes. This is a shift position, including day and night shift.  As a Process Specialist Downstream, a typical day might include, but is not limited to, the following: Liaising with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process Being the key person for technical input into manufacturing records, batch sheets and procedures Writing and reviewing, Standard Operating Procedures or other controlled documents as needed Providing technical input to resolve process problems both on and off the production suites Working closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve...

We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

Within this role you will be responsible to provide key technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support. This is a 12-month temporary contract As a Temp MSAT Specialist, a typical day will include, but is not limited to, the following: Assessing manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities Generating facility fit assessments and high-level gap assessments Generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments) Presenting options to resolve technical challenges and seeking endorsement Analysing process-generated data; summarizing findings in memos, reports, and presentations Reviewing manufacturing documentation generated...

Within this role you will be responsible for operational, maintenance and troubleshooting support for utilities, facilities, HVAC & building systems through strict adherence to Standard Operating Procedures (SOPs) and cGMP's. As a Maintenance Technician (Utilities) a typical day might include, but is not limited to, the following: Performing daily operations, maintenance and repairs on utilities, WFI, clean steam, bulk gases, bulk chemicals, process water generation, boilers, chillers, chemical dosing systems, cooling towers, air compressors, LPHW skids, waste water treatment, biowaste inactivation skids or other mechanical equipment in a cGMP environment with minimal supervision Monitoring and interpreting readings on equipment, computer terminals/HMIs, switches, valves, gauges, alarms, safety devices and meters to detect leaks or malfunctions ensuring that equipment is operating efficiently and safely Identifying any off-nominal conditions with mechanical...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron’s sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, and maintaining Regeneron’s sophisticated biopharmaceutical manufacturing processes at our Industrial Operation and Product Supply site and at IOPS contract manufacturing partner sites. As a Senior Automation Engineer (CMO Support), a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering...

Regeneron, located in Tarrytown, NY is seeking an energetic Process Development Engineer I to support technology transfer and business operations in the Technology Transfer & Logistics (TT&L) group within Preclinical Manufacturing and Process Development. In this role, you will lead production process transfer to support preclinical and clinical manufacturing at internal and external sites, as well as manage and coordinate a wide variety of departmental business operations. A Typical Day in This Role Might Look Like: Lead cross-functional teams to complete process transfer and establishment of production processes at internal and external clinical manufacturing facilities, with a focus on early-stage programs. Work to ensure the successful start-up of manufacturing production campaigns. Drive team cooperation to facilitate resolution of cross-functional issues and/or provide value-adding solutions. Ensure effective, accurate and timely communication...

Within this role will manage the day-based support requirements of the manufacturing operations team while providing direction, troubleshooting and guidance while maintaining safety compliance and audit readiness and ensuring objectives are delivered to a high standard and on time. As an Associate Manager Biotech Production (Downstream Operations) a typical day may include, but is not limited to, the following. Ensuring that all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate, reviewed and in accordance with regulatory requirements Leading, motivating, and managing the operation manufacturing specialist teams Preparing reports by collecting, analysing, and summarizing information and trends Tracking of relevant metrics to ensure operations are performing effectively and efficiently Implementing a contamination free program to ensure highest process success rates Working to the highest safety standards and supports...

Within this role you will be responsible for providing support, direction and subject matter expertise on equipment reliability issues to Facilities Production, Utilities and HVAC teams. You will be evaluating current plant equipment for reliability and assesses alternative options available. The role involves maintaining data of current equipment performance to identify and prevent potential reliability issues & implement reliability monitoring programs to provide maximum uptime of equipment. As a Senior Reliability Engineer a typical day might include, but is not limited to, the following:   Leading reliability improvements to identify opportunities in advance to support planned and predictive replacement versus reactive replacement using existing and developing technologies Providing support, direction and subject matter expertise on mechanical reliability issues Producing and implementing the site reliability policies for all equipment and...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron’s sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5...

The Protein Expression Sciences - AAV team at Regeneron, located in Tarrytown, NY, is seeking an independent and highly motivated Sr Scientist to support the stable cell line development of viral vector technology. In this exciting role, yowill be conducting research activities around the design, characterization, and validation of engineered adeno-associated viruses  ​(AAV) components stable integration, to build a novel platform to Regeneron’s gene therapy technology. As a Sr Scientist, a Typical Day Might Include: Designing gene expression vectors. Performing molecular biology techniques (Cloning, Western blotting, DNA/RNA extractions, PCR, RT-PCR, quantitative PCR, etc.). Creating and validating stable integration cell lines.  Developing cell-based assays to analyze AAV vectors efficacy. Working collaboratively with team members, and with collaborators in various therapeutic focus areas and core facilities across research and discovery. Participating in team...

Within this role you will be responsible for the administration, configuration, implementation, maintenance and ongoing support of various manufacturing equipment specific applications and systems in a cGMP environment. As an Automation Engineer a typical day might include, but is not limited to, the following: Providing end-user support for small manufacturing equipment applications including troubleshooting issues and appropriately communicating items to management, business process owners and users Working on equipment ranging from standalone equipment such as UV Specs, pH meters, particle samplers to networked equipment such as wave rockers, chromatography skids and cell analysers Overseeing and execution of automation preventative maintenance activities Being responsible for generating automation documentation such as SOPs, work instructions and configuration specification documents Performing daily business administrative tasks related to functional...

Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility.  Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.   Note, this is a shift based role (12/7 - extended days) As a QC Micro Analyst a typical day might include, but is not limited to, the following: Entering a laboratory cleanroom’s to collect and log samples for microbial analysis Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs) Performing sample analysis for microbial identification Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas Performing acceptance testing of commercially prepared microbiological culture media. Autoclaving microbiological media and laboratory waste as needed Ensuring that all work...

Career Category Information Systems Job Description Job Description – Specialist Information Systems (OSI Pi Data Historian) ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Title: Specialist Information Systems (Pi Data Historian) Location: Amgen India Role Description The Specialist Information Systems (Pi Data Historian) is responsible for owning, administering, and providing technical leadership for OSI Pi and related Manufacturing Information Systems in a GMP-regulated environment. The role focuses on integration with process equipment and...