- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to ... records.Support CAPA site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good Manufacturing Practices… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... and Local Leaders. Interacts with other HR colleagues, global colleagues, legal and compliance , employees and hiring managers at all levels of the business. External… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Merck & Co. (Durham, NC)
- …PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical ... and repair of equipment using Hazardous Energy Control Procedures (HECPs) Compliance with current good manufacturing procedures(cGMP), safety and environmental… more
- Merck & Co. (Durham, NC)
- …Electrical Maintenance, Electronics Instrumentation, Equipment Commissioning, Equipment Maintenance, GMP Compliance , HVAC Systems , Hydraulic Systems , ... and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is ... role will include:Partner with scientific teams across AR&D to drive compliance and operational excellence Onboard, qualify, and maintain laboratory equipment and… more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... improve performance.Apply technical skills and ingenuity to correct equipment and system problems that result in downtime or consume excessive maintenance resources… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, ... protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide… more
- Merck & Co. (Boston, MA)
- …resource utilization and maintain up-to-date awareness of literature-related copyright compliance , vendor tools, and information retrieval strategies.-If you thrive ... requests with Library team membersManaging access to external information systems such as databases, literature platforms, and pharmacopoeiasCollecting and reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Aequor (Swiftwater, MN)
- …water systems , cooling towers Replacement of valves and piping system repair Knowledge of SAPrs Capable of learning basic chemistry analysis Certifications ... wide equipment Completion of work orders and time entries into the SAP system Completion of all assigned training modules, SOP's, SWI's, safety, and compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of IT system architecture and cloud-based environments.Manage third-party vendors, system providers, and validation partners to ensure compliance , contract ... - Preferred Experience10+ years of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/medical device industry… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing… more
- Aequor (Devers, TX)
- …Data Migration Support: Support and lead all discussions on data migration and ensuring data compliance from one ERP System to the other. Data Testing: Act as ... User Acceptance Testing ensuring the right strategy and data compliance in applied. Update, create, and approve all necessary...etc. Vendor Setup: Manage vendor setup from one ERP System to another ERP Systems (ie, Oracle… more
