26 facilities jobs found in Rensselaer, NY

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

The Manager, Global Procurement – Facilities & Capital Equipment, will report to the Associate Director, Global Procurement – Facilities, Capital & Logistics (FC&L) and is responsible for developing and driving strategy for our responsible categories such as facilities services, capital equipment, and construction. They work collaboratively with teammates as well as cross-functionally with partners across all Regeneron campuses. The Manager owns supplier relationship, actively participates in supplier selection, and manages ongoing performance and service delivery. A Typical Day may include: Leading and collaborating with others to solve issues of diverse scope and provide analysis considering current business trends Continuous Improvement projects to improve efficiency and produce high quality work Negotiating internally and externally to get the best value for Regeneron Drafting and negotiating contracts (regional/global), while working with internal legal...

We are currently looking to add a Cleanroom & HEPA Certification Specialist to 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 Cleanroom & HEPA Certification Specialist will support our manufacturing by coordinating the performance of preventive maintenance and on-demand work of certification activities. As a Cleanroom & HEPA Certification Specialist, a typical day might include the following: Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled PM or general work Working with Certification Vendor(s) and Regeneron Facilities, Manufacturing and Lab Management Scheduling Groups to ensure timely certifications of HEPA filtered areas and equipment Recording certification activities in electronic records Ensuring safe and efficient maintenance of all Cleanroom and HEPA supplied...

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...

We are currently looking to fill a Supervisor Quality Assurance (Batch Record Review) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Providing consultation or advice in alignment with QA policies Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk Reviewing, editing, or approving Regeneron controlled documents Reviewing and approving of investigations associated with raw materials, product, laboratory,...

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...

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...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

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...

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 hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure manufacturing documentation a nd implementation aligns with Process Transmittals and meet the requirements of Regeneron’s quality system. In this role, typical day may include: Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Train and/or mentor junior employees, including providing insights and education on processes and procedures. Provides consultation or advice in alignment with QA policies. Review, edit, or approve Regeneron controlled documents. Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement. Responsible...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

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...

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...

We are currently looking to fill a QA Inspection Specialist position. This position will support Visual Inspection operations performed at Regeneron’s Internal Fill/Finish facility.  This position will provide floor support during production activities and also contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.     Available Working Schedule: Monday-Friday, 2nd shift (2p-10:30p) In this role, a typical day might include the following: Oversee programs to support Visual Inspection Operations at the Drug Product facility. Ensure that facilities, equipment, materials, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other Regeneron controls. Execute daily operations, including, but limited to: Providing Quality Oversight and...

We are currently looking to fill multiple Quality Assurance Specialist (Drug Product) positions. These positions will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. Available Work Schedules: Sunday-Wednesday, 1st shift (4x10) Monday-Thursday, 3rd shift (4x10) In this role, a typical day might include the following: Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team. Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc....

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview At Exact Sciences, we are cancer fighters. We are united by our mission to change lives by providing earlier, smarter answers. Through advances in cancer detection and treatment guidance, we will help eradicate the disease and the suffering it causes. A Screening Solutions Specialist (SSS) is a front-line position in the fight against cancer. The SSS will drive product growth of Cologuard in medical practices to meet sales goals within the assigned geography and deliver diagnostic solutions by establishing the importance of Colorectal Cancer (CRC) diseases and screening. This role...