18 jobs found in Gurgaon Haryana

Career Category Quality Job Description QA Specialist- Document Management System (DMS) Tech Writing & Operations Support Let’s do this. Let’s change the world Roles & responsibilities: As integral part of the DMS technical writing team member working globally with Quality operations activities and other requirements: Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents. Support optimization and maintenance of the DMS process, including updates to the procedure, the system (CDOCS), and associated training materials Maintain and enhance DMS document templates and authoring standards to ensure consistency and compliance Lead technical writing tasks in support of process and document simplification efforts. Execute standard and streamlined document creation/revision process following a hierarchy structure and templates per procedures and approved protocol Responsible...

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 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 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...

Career Category Information Systems Job Description 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 Description: Let’s do this. Let’s change the world. In this vital role you will leverage advanced analytics, AI, and GenAI capabilities to unlock insights and drive innovation in Amgen’s finance landscape. You will be an integral member of a dynamic product team that builds and deploys financial planning and AI-driven solutions, harnessing Finance data from Amgen’s enterprise data lake. If you are a passionate data scientist with a track record of applying...

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...

Regeneron is currently looking for a Drug Product (DP) MSAT (Manufacturing Sciences and Technology) Engineer for our Device Assembly and Packaging team. This role will serve as combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial). Serve as a technical representative for CMO selection strategy, equipment qualification activities, and be hands on solving issues during technology transfer and cGMP start up. The MSAT team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. As a DP MSAT Engineer, a typical day might include the following: Drives innovation in the area of device assembly, labelling and packaging by identifying the latest technological advancements and ensuring a creative environment and implementation aligning to business needs. Ensuring site to site consistency after the processes are optimally transferred, provide floor support during...

The Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical leadership, drive operational excellence, and foster a culture of safety, collaboration, and continuous improvement. A strong emphasis will be placed on quality and compliance, people management, team development, leadership, and succession planning. Essential Duties and Responsibilities include, but are not limited to, the following: Leading and the management of the process equipment engineering, maintenance, and calibration teams.  Providing engineering and technical support to manufacturing operations with specific focus on system and equipment continuous improvement. Owning the introduction of new process...

We are looking for an Ultra-Pure Water (Clean Utilities) Technician with a Wednesday – Saturday, 2:00pm – 12:30am schedule to join our growing team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Clean Utilities Technicians support the manufacturing process through involvement with start-up, operation, monitoring, maintaining and shutdown of clean utility systems and equipment within Clean Utility mechanical rooms. Please note this will be a Monday-Friday 1st shift 8:00am-4:30pm position for approximately 3-6 months for training. Working hours thereafter will be 2nd shift 2:00pm – 12:30am Wednesday - Saturday. As a Clean Utilities Technician, a typical day might include the following: Performing preventative and predictive maintenance on related clean utilities and systems that support manufacturing. Maintaining water rooms and related...

We are currently looking to fill a Manager External Manufacturing position. This position strategically leads business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners through the External Manufacturing Team. They will strive to achieve a consistently high level of interaction to meet or exceed Regeneron’s business needs relating to product quality, availability and delivery. They will ensure that all critical external manufacturing requirements are implemented to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains. The role of the Manager External Manufacturing is to act as the Relationship Lead with the CMO/Partners or as the Operations Lead within the External Manufacturing Teams. In this role, a typical day might include the following: Ensuring that product manufacture occurs in compliance with cGMP and applicable regulations. Facilitates all...

We are currently looking to fill a Process Technician position with a Wednesday-Saturday 6:00 a.m.-4:30 p.m. schedule. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance, and troubleshooting support for manufacturing process area maintenance through strict compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 6:00am-2:30pm for the first few weeks. Working hours thereafter will be Wednesday-Saturday 6:00am-4:30m As a Process Technician, a typical day might include the following: Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment Identifying any off-nominal conditions with mechanical equipment and mechanical troubleshooting of...

Within this role you will be responsible for supervising the implementation of commercial manufacturing production schedules. Supervising the manufacturing team in relation to process execution for Manufacturing processes. This is a shift position. As a Supervisor Biotech Production, a typical day might include, but is not limited to, the following: Supervising commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule. Supervising a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment. Ensuring that the highest safety and housekeeping standards are maintained. Supervising all aspects of respective areas of operations. Reviewing and editing batch records in accordance with cGMP standards. Ensuring availability of production batch records for upcoming lots. Scheduling duties and batch tasks based on master production schedule. Ensuring equipment readiness...

We are currently looking to fill a Plant Utilities Technician position with a Wednesday-Saturday 6:00am-4:30pm schedule. Our Plant Utilities Technicians are responsible for start-up, normal operation, monitoring, maintaining and shutdown of Plant Utility systems and equipment within Plant Utility mechanical rooms that support overall facility buildings. Please note training will be Monday-Friday 7:00am-3:30pm for the first few weeks. Working hours thereafter will be Wednesday-Saturday 6:00am-4:30pm. As a Plant Utilities Technician, a typical day might include the following: Maintaining high pressure steam and hot water boilers, controls and associated equipment Maintaining boiler and cooling tower chemical treatment program Maintaining all other Plant Utility equipment such as boiler pretreatment water, condensate return, natural gas, domestic potable water, tepid water, wastewater Monitoring controls of plant systems using Building Automation System (BAS) or...

We are currently looking to fill a Process Technician position with a Saturday-Wednesday 10:00pm-8:30am schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance, and troubleshooting support for manufacturing process area maintenance through strict compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 7:00 a.m. - 3:30 p.m. for up to six months. As a Process Technician, a typical day might include the following: Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment...

We are currently looking to fill a Process Technician position with a 6:00am-4:30pm Sunday-Wednesday schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance, and troubleshooting support for manufacturing process area maintenance through strict compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 6:00am-2:30pm for up to six months. As a Process Technician, a typical day might include the following: Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment Identifying any...

We are looking for an Ultra-Pure Water (Clean Utilities) Technician with a Saturday-Wednesday 10:00pm – 8:30am schedule to join our growing team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Clean Utilities Technicians support the manufacturing process through involvement with start-up, operation, monitoring, maintaining and shutdown of clean utility systems and equipment within Clean Utility mechanical rooms. Please note training will be Monday-Friday 8:00am-4:30pm for approximately 3-6 months. Working hours thereafter will be Saturday-Wednesday 10:00pm – 8:30am. As a Clean Utilities Technician, a typical day might include the following: Performing preventative and predictive maintenance on related clean utilities and systems that support manufacturing. Maintaining water rooms and related equipment such as pumps, motors, Water for...

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...

We are currently looking for a Fill/Finish Operator. Regeneron optimally manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Fill/Finish Operators perform tasks vital to support aseptic filling manufacturing processes. They work individually, and as part of a team, to support operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for biological products. Our Operators seek to understand and develop proficiency in a wide range of processes or procedures of growing complexity. As a Fill/Finish Operator, a typical day might include the following: Provides support for the operation of, and may independently operate, a mix of manual and brand new automated equipment such as washers, autoclaves, filling equipment, labelers, cartoners, syringe and device assembly machines according to applicable procedures based on training and operator level....