- Legend Biotech USA, Inc. (Raritan, NJ)
- …Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Familiarity with core Quality Management System processes.Strong written ... of multiple myeloma.Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality team...in a manner consistent with the safety policies, quality systems and cGMP requirements.Review change controls, SOPs, and other… more
- Merck & Co. (Rahway, NJ)
- …You will operate at the intersection of executive strategy, software delivery, control systems engineering and shopfloor operations - shaping the technical ... and regulatory requirements; manage risks from integrations and on-prem/edge control systems . Collaborate with Infrastructure, Cybersecurity and Architecture… more
- Merck & Co. (Durham, NC)
- …(eg washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)-Automated Systems (eg Distributed Control System (DCS), Programmable ... managerStrong knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems within the following disciplines:- Conductivity, Low Frequency… more
- Merck & Co. (Durham, NC)
- …activities are tracked and completed Develops detailed understanding of design, construction, control and maintenance of building systems and process equipment. ... Skills: CMMS experience related to plant maintenance and spare parts procurement systems Project management, including change control and equipment qualification… more
- Merck & Co. (Rahway, NJ)
- …and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems . Manage the development and oversight of site operations through ... Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems , Project Management, Regulatory Compliance, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …System administration and lifecycle management for automated and digital systems : Programmable Logic Controllers (PLCs), Supervisory Control and Data ... business prioritiesSystem administration and management of the following automated systems :Programmable Logic ControllersSupervisory Control and Data Acquisition… more
- Merck & Co. (Rahway, NJ)
- …experience maintaining validated automation systems , executing change control , investigations/CAPA, periodic reviews, system administration (eg, user/role ... reportingOT/IT: Industrial networking, virtualization (eg, VMs), databases/historians, and basic system administrationExperience with electronic validation and quality systems… more
- Merck & Co. (NC)
- …work activities with department objectives Project management Experience involving utility system generation, distribution and control are preferred. Lead in ... facility. This support position will focus on investigation of utility/facility system excursions, system improvements and optimizations. The incumbent will… more
- Merck & Co. (Durham, NC)
- …you! Description The Specialist, Manufacturing Automation, is responsible for Building Automation System (BAS), cold storage, and utility systems for the Digital ... activities Authoring, or peer reviewing automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control , and other key… more
- Cipla (Fall River, MA)
- …of deviation, CAPA, change control , FMECA and training. Knowledge and handling of SAP system , master control and Track wise system . During audit part of ... to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate… more
- Cipla (Reid, WI)
- … control , FMECA, OOS, OOT, training and OOAC. Knowledge and handling of SAP system , master control and TrackWwise system . Knowledge of p reparation of ... management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established timelines. Autonomously leads… more
- Merck & Co. (Rahway, NJ)
- …GMP Compliance, Good Manufacturing Practices (GMP), Interpersonal Relationships, Inventory Control System , Key Performance Indicators (KPI), Logistics, Materials ... & Microsoft PowerApps. - Works directly in the SAP system to ensure a robust and consolidated forecast for...relationship management. - Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support ... of the project plans for electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …System (BAS) and Environmental Monitoring System (EMS)Quality Investigation / Change Control System / Documentation System (Track wise, Comet, Veeva ... to ensure the facility is in a state of control and update / communicate with all teams with...Vault, etc )Manufacturing Execution System (MES)#Li-DD1#Li-OnsiteThe anticipated base pay range is$107,482—$141,070 USDBenefitsWe are… more
- Syner-G BioPharma Group (Boston, MA)
- …strategic guidance and hands-on expertise to streamline operations, enhance quality systems , and ensure regulatory compliance, empowering our clients to navigate ... plant operations, including labs, manufacturing plants, utilities, equipment, and systems . The ideal candidate will perform routine inspections, maintain documented… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control , risk management, material and molding, design validation to create and ... process.Skilled in laboratory good documentation practices and electronic documentation systems .Self-motivated with ability to work independently.Proven ability to lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in developing, writing and approving technical documents.Experience with Quality systems (Change control , investigations, LIMs, etc.).Extensive technical writing ... scope includes working on Quality related sub-teams such as change control sub-teams and investigational sub-teams. The material/ raw material scope includes… more
- Merck & Co. (Rahway, NJ)
- …will focus on designing, implementing, and optimizing automated laboratory systems to accelerate pharmaceutical process development while ensuring operational ... to achieve improved performance, accessibility, maintainability, and reliability.Integrate robotic systems with existing laboratory equipment and data capture … more
- Merck & Co. (North Wales, PA)
- …holds direct account and contract responsibility across the US health care system - including pharmacy benefit managers (PBMs), health plans, state Medicaid ... with other areas of our Company to address and manage business, process and system issues; will perform end to end activities of accounting for units of product… more
- Merck & Co. (Rahway, NJ)
- …qualification activities for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification of complex ... systems .-The candidate is expected to build inclusive, collaborative partnerships...experiments to create effective shipping solutions to maintain temperature control and physical protection.Provide subject matter expertise and ensure… more
