- Insmed Incorporated (San Diego, CA)
- …strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when managing cloud applications. Manage and provide oversight on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based ... MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both within… more
- ValSource, Inc. (Durham, NC)
- Validation Specialist / Validation Engineer / CQV Engineer ValSource is currently looking to identify experienced and technically skilled leaders in ... Commissioning, Qualification and Validation Engineering to support a variety of exciting projects with clients our clients in the pharmaceutical and biotech… more
- Cipla (Hauppauge, NY)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY ... 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role performs… more
- ValSource, Inc. (Rahway, NJ)
- …throughout each of our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be responsible for ... preparing and executing commissioning, qualification, and validation protocols and documents for a variety of utilities, facilities, and process equipment used in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders ... clinical data programming, reporting, data visualizations, external data acquisition and validation , and tools to support project portfolio across drug programs.… more
- Merck & Co. (Rahway, NJ)
- …and device product development, such as manufacturing process development and validation , design control, risk management, material and molding, design validation ... input(s).Lead establishment of test methodologies, including method development and validation , internally or externally, per design verification strategy.Lead strategy… more
- Insmed Incorporated (NJ)
- …will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when managing cloud applications. Manage and provide oversight on… more
- Aequor (San Diego, CA)
- …Summary:Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems.Serve as the CSV ... procedures relating to quality, data integrity and computer system validation .Primary Responsibilities:Responsible for supporting the Computerized System project teams… more
- Insmed Incorporated (NJ)
- …to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional teams and ... patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech, or healthcare) environment… more
- Eisai, Inc (Baltimore, MD)
- …and coordinate calibration activities to support ongoing compliance, validation activities, operations activities, maintenances schedules, new equipment/instrument ... duties outside of Metrology to include but not be limited to validation /revalidation activities, cross training in operations and execution of production processes,… more
- Insmed Incorporated (NJ)
- …management, and reviews of validated systems. Author CSV Documents ( Validation Plans and Summary Reports) Assist/co-author requirements, testing, specification, and ... other validation project deliverables Ensure training requirements are complete for...and Education): 3+ years' hands on experience in a validation role with responsibility for computer systems specifically LIMS,… more
- ValSource, Inc. (Worcester, MA)
- …with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management ... Leadership & Collaboration Lead cross-functional teams across engineering, quality, validation , and operations. Collaborate with Jacobs project teams and internal… more
- Insmed Incorporated (NJ)
- …control laboratories and other GxP areas, with a focus on data integrity, validation , and inspection readiness. The Sr. Quality Engineer will partner with IT, ... compliance with FDA, ICH, and EU regulations.Review and approve computer system validation (CSV) deliverables (eg, URS, FS, validation plans, protocols, reports,… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Eisai, Inc (Exton, PA)
- …release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in ... release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in… more
- Merck & Co. (Rahway, NJ)
- …play a crucial role in the supporting the development, analytical validation , and testing of histopathology-based assays for clinical implementation and advancing ... by our company's therapeutics.Collaborate in the development and analytic validation of digital pathology algorithms.Interface with scientists and physicians in… more
- Merck & Co. (South San Francisco, CA)
- …a clinical insight into the earliest stages of target identification and validation , and executing clinical studies to evaluate the relevance of potential targets ... interrogate biological activity in humans.Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or… more
- Merck & Co. (Durham, NC)
- …Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation . Position Description: Durham-Technology consists of the Automation/MES, ... Deviation Management, Manufacturing Technical Operations, Validation , and New Product Technical Transfer Departments.The Associate Specialist - Process Engineer will… more
- Eisai, Inc (Exton, PA)
- …high-quality output on time. Coordinate equipment maintenance, calibration, and validation with appropriate internal departments. Troubleshoot equipment as necessary ... Upstream/Downstream Operations , Facilities, R&D, Quality Assurance, Quality Control, Validation , and other internal and external functions to support successful… more
