- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:We're looking for a Sr Manager, IT Clinical Systems Validation in the IT team to help us expand what's possible for patients with ... to lead the planning, execution, and documentation of computer system validation (CSV) activities for clinical applications. You'll also:Collaborate with business… more
- Cipla (Hauppauge, NY)
- …employees working outside of Cipla's US Subsidiaries or Affiliates Job Description for Validation Engineer Role Summary The purpose of the Validation Engineeris ... and regulatory requirements. They do this by developing and implementing validation plans, conducting tests, analyzing data, and documenting results. Salary Range:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Validation Specialist III as part of the Quality team based in Raritan, NJ.Role ... OverviewThe QA Validation Specialist role is an exempt level position with...position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems,… more
- Cipla (Fall River, MA)
- Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General Shift: 8:30AM - 5:00PM (may vary ... is searching for experienced candidates for the position of Manufacturing Validation Engineer . The Manufacturing Validation Engineer is responsible… more
- Syner-G BioPharma Group (Boston, MA)
- …information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is ... specifications, design & development of process parameters, and the commissioning/ validation of manufacturing processes for compliance with quality and regulatory… 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
- Cipla (Hauppauge, NY)
- …role will perform IT Systems Support including Systems Implementation, Validation , Administration etc., for Manufacturing, Packaging, Warehouse, Quality etc., IT ... - MES partner Kevin - SCADA implementation partner PLC Vendors for validation activities Manufacturing and Packaging Machine Vendors QC Instruments vendor - Labware,… 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
- Cipla (Central Islip, NY)
- …partners. This role will perform IT Systems Support including Systems Implementation, Validation , Administration etc., for QC, QA, R&D, RA etc., IT project ... R&D and RA Application Vendors QC Vendors for Implementation, Upgradation, Validation and Qualification Activities LIMS/ELN Vendor (Labware) Dimensions IT QC, QA,… more
- Merck & Co. (Durham, NC)
- …Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control ... tools and calibration equipment)- Assist with execution of calibration, automation, validation and additional testing, as required Decisions are guided by policies,… 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
- 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
- Aptyx (Charlotte, NC)
- …and reliability testing plans for catheter systems, including the development and validation of accurate in-vitro and in-vivo models and methods Develop pilot and ... for devices Assess feasibility of processes and support manufacturing with validation plans and time studies Support product manufacturing until the project… more
- Merck & Co. (Rahway, NJ)
- …reporting, and visualization capabilitiesDevelop and complete appropriate system validation , Change Control and testing documentation, ensuring compliance with ... industryExperience with pharmaceutical facility and equipment commissioning, qualification, and validation (CQV)Development and execution of equipment and facility automation-related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements ... strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System Validation … more
- Merck & Co. (Durham, NC)
- …Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control ... tools and calibration equipment)-Assist with execution of calibration, automation, validation and additional testing, as requiredDecisions are guided by policies,… more
- Tris Pharma (Monmouth Junction, NJ)
- …field and minimum 8 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Master's degree in ... field and minimum 5 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or… 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
