1020 other jobs found in Raritan, NJ

Legend Biotech USA Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role Overview This position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require technical expertise and troubleshooting ability to drive effective and robust production, testing and release of product to patients. This person must be able to work 3rd shift/overnight hours....

Legend Biotech USA Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ . Role Overview The Operations Support Specialist will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule. Key Responsibilities Support process operations by performing support specific and real time floor service tasks (i.e., kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior for cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format. Perform tasks on time in a manner consistent with safety policies, quality...

Legend Biotech USA Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role Overview The MES Engineer will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X). Key Responsibilities Support eBR development, modeling, and deployment in MES Coordinate with other departments to gather user requirements, guage effort, and deliver robust, right first time EBR designs. Participate in design...

Legend Biotech USA Legend Biotech is seeking an Operations Associate (1st and 2nd shift openings available) as part of the Technical Operations team based in Raritan, NJ . Role Overview This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Key Responsibilities Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum. Execute manufacturing activities common to cell culturing, purification, aseptic processing, and...

Legend Biotech USA Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for management and delivery of the integrated project and program plans in the plant, ensuring alignment in support of the overall objectives and priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget project deliverables. The role will require proven leadership and expertise...

Legend Biotech USA Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to...

Legend Biotech USA Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and...

Legend Biotech USA Legend Biotech is seeking a Facilities Cleaning Program Lead as part of the Technical Operations team based in Raritan, NJ. Role Overview The CAR-T Facility Cleaning Lead is an exempt level position working within Maintenance and Metrology team. This individual will be responsible for managing the 3rd shift cleaners to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1st shift facilities and operations teams. The lead will work closely with the cleaning team to ensure all 3rd shift cleaners are compliant with the training and general manufacturing practices. Key Responsibilities Lead the 3rd shift cleaning team to ensure facility readiness for manufacturing operations and quality control labs next shift. Communicate with all key stakeholders (MFG, FAC, QC, etc..) any issues or concerns with facility cleanings. Performs daily walkthroughs of the...

Legend Biotech USA Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role Overview This position is responsible for the qualification of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program overseeing facilities, utilities, and equipment for Legend Biotech. The position is responsible for ensuring that the qualification activities are performed within an appropriate level of GxP compliance. This individual will need to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies within cell therapy Technical Operations. Key Responsibilities Interface between the Engineering group and the operating...

Legend Biotech USA Legend Biotech is seeking a Critical Equipment Expert as part of the Global Operations team based in Somerset, NJ. Role Overview This position will be responsible for calibration and maintenance support of mechanical system operations for cGxP Clinical Cell Therapy Manufacturing and R&D Laboratories. This individual will partner with various functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGxP requirements. They will require technical expertise and troubleshooting ability to support the Clinical Production Facility and R&D laboratories. This role will focus on critical operations equipment for reliability, calibration and PM completion, troubleshooting, scheduling, spare parts, and compliance to continually support site needs. This role supports operational activities, occasionally these activities will require support outside of the typically work schedule,...

Legend Biotech USA Legend Biotech is seeking a Metrology Support Specialist as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for metrology support for instrument and mechanical system scheduling, planning, and work order management for cGMP Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production. This position will also be responsible for supporting, planning and scheduling facility & engineering related activities. The role will require proven leadership and expertise that drives effective communication,...

Legend Biotech USA Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role Overview The Manager of CAR-T Investigations will be part of the Operations Investigations team and will be responsible for managing and leading different investigations work-cells, drive investigations to closure, support escalations, monitor and improve performance metrics for team. They will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies. Key Responsibilities Individual will lead a team to support manufacturing investigations, capacity planning, hiring, development, and performance management of its direct reports. Monitor day to day execution of investigations, maintain investigations metrics and take necessary actions to sustain metrics targets. Reports to management on trending and status as requested. Identify and implement process...

Legend Biotech USA Legend Biotech is seeking a Contamination Program Lead as part of the Technical Operations team based in Raritan, NJ . Role Overview The Contamination Program Lead will be responsible for creating and maintaining the contamination control strategy program for the Cell Therapy facility following necessary FDA / Annex 1 requirements. This person will be the lead for contamination program, working cross functionally with various departments to ensure equipment and facility can be proper disinfected / maintained in an environmental state of control. This role will require microbial and engineering technical expertise and troubleshooting ability and shall drive effective communication, coordination and collaboration across relevant cross functional groups. This individual will be an integral part of the CAR-T Environmental Monitoring Immediate Action team and Contamination Rapid Response Team in support of on-going clinical and commercial manufacturing...

Repligen Overview We are seeking a highly motivated and detail-oriented professional with a strong engineering background to join our team in a GMP-regulated environment. This role is ideal for someone who thrives at the intersection of technical problem-solving and quality compliance. The ideal candidate will bring a solid understanding of engineering principles, coupled with hands-on experience in regulated manufacturing settings, to support continuous improvement, process reliability, and adherence to GMP standards across operations. Responsibilities * Provide strategic leadership and direction to the Quality Management System (QMS), ensuring alignment with customer GMP requirements and Corporate Quality standards.* Drive the development and maturity of the QMS and the Quality team, embedding a quality-driven culture that supports the company's mission, vision, and goals.* Foster a customer-centric culture built on compliance, product integrity, and.* Establish and...

Repligen Overview The Regional EHS Manager is responsible for EHS at the NY and NJ sites as well as providing EHS support to Repligen's Services Business Unit. The Regional EHS Manager ensures that EHS risks are managed and ensures compliance with regulatory and industry standards. The main objective for the Regional EHS Manager is to protect our employees, customers, organization, and the environment. This role identifies potential hazards and conditions and works cross-functionally to continually mitigate risk and improve workplace operations. As the regional EHS leader, this role recommends solutions to protect workers and the environment, trains employees on how to work safely, and maintains documentation of EHS programs, procedures, and activities. This role works in conjunction with HR and other managers to manage incident claims, investigations, root cause, and to develop and verify actions for prevention. While primarily working from the NJ facility, this role will...

Ameriprise Financial Do you have experience in the financial services industry and want to advance your career with an industry-leading firm? Our office is growing, and we are looking for a Client Service Associate to join our operations team! The Client Service Associate (CSA) is an integral part of advisor and branch support; responsible for using the client relationship model and turnkey tools. Activities may include but are not limited to servicing clients by assembling and analyzing client data, helping prepare financial plans, working with clients to process transactions, trades and other practice management tasks as needed. In addition to supporting advisor(s), you'll be a part of our operations team providing the branch with general administrative and reception support as needed, including but not limited to understanding firm policies, procedures and digital tools. At Ameriprise Financial, we take pride in providing our clients with a personalized experience every step of...

Vivint Welcome to the intersection of energy and home services. At NRG, we're driven by our passion to create a smarter, cleaner and more connected future. Vivint Smart Home, an NRG owned company, is a leading smart home company in the United States, dedicated to redefining the home experience with intelligent products and services. We find purpose in proactively protecting and keeping our customers connected to home, no matter where they are. Join the Smart Home team to create smarter, safer and more sustainable homes. We are adding to our Field Service Technician team and looking for motivated, customer-focused, coachable individuals who have a knack for technology and sales. Why Join Our Technician Team? Competitive hourly base plus uncapped commission Comprehensive paid training & Ongoing coaching and support Company take-home vehicle and gas card Cell phone and work tablet We provide all tools necessary to perform the job - We'll ship...

Strategic Education Inc. Capella University offers two learning formats, FlexPath and GuidedPath, to provide a flexible and affordable way for working professionals to earn a degree designed to fit into their life. Our FlexPath learning format offers asynchronous 12-week courses with self-paced target dates to put learners in control of completing the course within 12 weeks of enrollment. Rolling enrollment allows learners to finish a course early and advance to the next course mid-quarter without having to wait. Faculty help learners progress by providing competency-based evaluations within 48 hours of assessment submissions, excluding weekends and holidays. Essential Duties & Responsibilities: Assignments are on an ongoing rolling enrollment basis according to expertise and school needs. Utilize your professional expertise to provide high quality instruction from a pre-designed curriculum. Be available within 48 hours (excluding weekends and holidays) by...

Strategic Education Inc. The Assistant Instructor is responsible for providing instructional and academic support to learners in courses. This support will be offered through: 1:1 coaching and consultation, instructional materials and resources, and the facilitation of office hours or group study sessions. Essential Duties & Responsibilities: Building an online community conducive to the spirit of learning and continuous improvement in a positive, learner-focused environment. Using text, video, and other technologies to create learning resources that drive learner engagement and assist learners with course content and skill development. Leading and commenting in courseroom discussions with learners. Planning and facilitating optional weekly interactive, collaborative study and review sessions that combine what to learn (content) with how to learn (study strategies). Assessing learning and comprehension through evaluation of course competencies; this may include...