- Legend Biotech USA, Inc. (Raritan, NJ)
- …enhancements within a GMP site.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate MES validation activities according to the ... of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support… more
- Insmed Incorporated (NJ)
- …role serves as the IT System Owner for the Learning Management System and compliance IT systems , which includes supporting GxP-regulated applications, while ... while ensuring system integrity and regulatory adherence throughout the system lifecycleEnsure systems meet business needs and operational requirements while… more
- Merck & Co. (Durham, NC)
- …Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation .The Maurice R. Hilleman Center for Vaccine Manufacturing is located ... technology transfer focusing on either upstream, downstream, and/or culture media/support systems .Off-shift and weekend coverage will be required based on business… more
- Cipla (Fall River, MA)
- …maintenance of records of the purified water generation, storage, and distribution system . Participate in qualification and validation activities for effective ... the site internally and externally. Install and troubleshoot facility electrical systems . Coordinate with central utility so that required quality utilities can… more
- The Computer Merchant, LTD. (Plano, TX)
- JOB TITLE: Senior Systems Engineer - MBSE JOB LOCATION: Plano, TX, Dayton, OH, or Denver, CO WAGE RANGE*: 70-96 JOB NUMBER: 25-03813 Clearance Requirements: Active ... DESCRIPTION: Our client, a large defense contractor, has an immediate opening for a Senior Systems Engineer - MBSE to work from one of three locations in Plano, TX,… more
- Formation Bio (New York, NY)
- …Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice President ... there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will involve leadership and… more
- Aequor (Fort Worth, TX)
- …of automation systems while ensuring safety, and validating the automated system for alignment to requirements, CGMPs, and intended system operation. ... out engineering project work with minimal direction. Troubleshoots equipment/process control systems and change control activities. Programs PLCs, HMIs, SCADA … more
- Cipla (Fall River, MA)
- …of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory ... mitigate impact. Reviews document for accuracy and completeness. Defends the validation programs and strategies to customers and regulatory auditors. Performs weekly… more
- Cipla (Fall River, MA)
- …Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, ... approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents,… more
- Twist BioScience (South San Francisco, CA)
- …record of writing detailed business requirements, mapping processes, and supporting system testing and validation .Ability to translate scientific or customer ... CA or Carlsbad, CA)About the RoleAt Twist Bioscience, we're scaling the digital systems that power our synthetic DNA platform and enable innovation across our… more
