- 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
- 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
- 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
- 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
- Formation Bio (New York, NY)
- …Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice President of Quality ... there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will involve leadership and guidance… more
- Cipla (Fall River, MA)
- …role will perform IT Systems Support including Systems Implementation, Validation , Administration etc., for Manufacturing, Packaging, Warehouse, Quality etc., IT ... IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC. SAP Skills in Production, WH, Packaging and Quality modules … more
- AUROBINDO (Durham, NC)
- …for study types ranging from reverse engineering to method development/ validation to product characterization.. Drafts protocols and performs experiments ... owner, software system owner, metrology, hazardous waste management, software validation , ELN template development/ validation , instrument qualification, etc.Writes… more
- BioAgilytix (Durham, NC)
- …Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and ... into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA, EMA, or sponsor… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert in Genomics assay development and fit-for-purpose analytical validation to enable biomarker testing in clinical trials across all therapeutic ... Strong background in Genomics based assay development and analytical method validation with extensive knowledge and experience with regulated assays, standards and… more
- Merck & Co. (Durham, NC)
- …work requests.- This position will work in conjunction with Facilities, Engineering, Validation , Manufacturing, and Quality Departments to help the company and all ... task lists, etc., as required.Assists with execution of automation, validation , and additional testing, as requiredResponsible for written documentation of… more
- Cipla (Reid, WI)
- …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
