- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, ... NJ. Role OverviewThe QA Validation Specialist role is an exempt level...role will also provide oversight of technical, qualification, and validation activities including data or document review… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist , Global Development Quality Operations - API, is responsible for independent review and approval ... and/or regulatory inspections. Independently performs audits of batch documentation, data , information, procedures, equipment and systems, and/or facilities to… more
- Merck & Co. (Rahway, NJ)
- …company's Research Laboratories Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey research ... facility. The Metrology and Validation Specialist will work as part of...Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity and Inclusion… more
- Cepheid (Miami, FL)
- …the Danaher Business System which makes everything possible.The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay ... apply scientific knowledge to plan, design, development, test, analyze testing data and document stability studies to establish the product shelf-life.This position… more
- Boehringer Ingelheim (St. Joseph, MO)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , CSVC oversees all aspects of computer system and computer system and ... computerized equipment validation within BIAH Operations, including program implementation of corporate...to ensure GxP regulatory compliance. The incumbent leads key data integrity assessment, remediation activities as well as GxP… more
- Catalent Pharma Solutions (Harmans, MD)
- **Lead Specialist , QA Validation & Engineering** Catalent Pharma Solutions is looking to hire a **Lead Specialist , QA Validation & Engineering** to ... will house 8 CGMP manufacturing suites and cold storage warehousing. The **Lead Specialist , QA - Validation & Quality Engineering** is responsible for providing… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... If completed by an external company, the computer systems validation (CSV) specialist will be responsible for...and change in timelines. Understanding of FDA requirements for validation . The ability to analyze and interpret data… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is hiring a Principal QA Validation Specialist (Equipment Qualification)! In this role, you will play a critical part in ensuring the validation ... or related field and the following years of experience for each level: + Sr QA Validation Specialist : 5+ years + Principal QA Validation Specialist : 8+… more
- Actalent (Durham, NC)
- … testing, ensuring timely and documented approval prior to routine use. + Analyze validation data to ensure acceptance criteria are met and assist in writing ... Quality Specialist - Validation Job Description The Quality Specialist - Validation ensures adherence to current Good Manufacturing Practices (cGMP) and… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an integral part of the ... Provide guidance on quality issues that affect the integrity of data or system validation + Maintain accurate inventory of all applications, hardware, and… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... controlled temperature unit (CTU) operations. + Ability to perform data review and trend analysis to support validation... data review and trend analysis to support validation conclusions. + Familiarity with laboratory sample handling and… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... controlled temperature unit (CTU) operations. + Ability to perform data review and trend analysis to support validation... data review and trend analysis to support validation conclusions. + Familiarity with laboratory sample handling and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory requirements ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**...carrying out, and reviewing master and completed qualification and validation protocols, summary reports and associated data … more
- SMBC (White Plains, NY)
- …continuous improvement of the model quality and governance. The Sr Model Validation Specialist applies numerical, statistical and qualitative knowledge to ... of the Risk Management Department, the Model Risk & Validation department enhances the Model Risk Management framework for...and model development; and working with large and complex data sets. Ability to apply regulatory requirements outlined in… more
- Kelly Services (West Point, PA)
- …capital purchasing and initial installation of computerized analytical systems prior to validation . + Participate in various data integrity and lab modernization ... **Metrology Specialist I** **Location: 100% On-site in West Point...engineer to identify resolutions + Participate in computer system validation activities associated with new or upgraded equipment or… more
- BioBridge Global (San Antonio, TX)
- …skills and be able to identify and solve issues that arise during the validation process. Must possess data analysis and interpretation skills to effectively ... possess data analysis and interpretation skills to effectively evaluate validation results. **Working Environment** Works in a well-lighted air conditioned and… more
- Kedrion Biopharma (Melville, NY)
- _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play a critical role in ensuring the compliance and reliability of ... environments. As a Subject Matter Expert (SME), you will lead validation efforts and support the development, commercialization, and lifecycle management of… more
- Sartorius (Yauco, PR)
- As the Validation Laboratory Specialist , you will contribute to the accomplishment of different task of the laboratory, integrating his knowledge, experience and ... with project management and stakeholders. + Define test approaches and support validation documentation. + Manage laboratory information and data reports. +… more
- Legrand NA (Reno, NV)
- Position Description At a Glance Legrand has an exciting opportunity for a Test & Validation Technician to join the Data , Power and Control Team in Reno, NV. ... general supervision of the Operations Engineering Senior Manager, the Test & Validation Technician will support the Operations Department by ensuring new products… more
- VTI Life Sciences (San Diego, CA)
- …Life Sciences industries. We are looking to staff a highly motivated Validation Specialist / Engineer 1 responsible for delivering commissioning, qualification, ... and validation (CQV) services related to equipment, instruments, and systems...with Autoclave Qualification. + Experience with Kaye Validators and data loggers is a huge plus. + Previous experience… more
