- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Sr . Specialist , IT Application Support as part of the IT team based in Raritan, NJ. Role OverviewWe are seeking a highly skilled and ... proactive Sr . Specialist , IT Application Support to provide...S/4HANA, MES, or other manufacturing platforms.Knowledge of Computerized System Validation proceduresKnowledge of cell therapy specific needs in manufacturing… more
- Novo Nordisk Inc. (Durham, NC)
- …department. Position will also be responsible for the production activities & validation . Ensuring relevant compliance issues are addressed & handled in close ... Authority for product release Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role OverviewThis position will be ... responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual… more
- Kedrion Biopharma (Melville, NY)
- …and ensure success through the commercialization lifecycle. **ESSENTIAL JOB FUNCTIONS** Supports Sr . Validation Specialist on process improvement projects. ... hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Associate Validation Specialist at Kedrion provides technical input to Kedrion's… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... services to solve your most difficult development and manufacturing challenges The ** Senior Cleaning Validation Specialist ** position involves creating… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation department is hiring! The Principal QA Validation Specialist validates and qualifies equipment, systems, and processes in accordance with ... + Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME)...following years experience for each level: + Principal QA Validation Specialist : 8+ years + Staff QA… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Science, IT or related field and the following years of experience per each level: + Sr . QA Validation Specialist : 5+ years + Principal QA Validation ... We are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation … more
- Curia (Rensselaer, NY)
- Senior Quality Assurance Validation Specialist in Rensselaer, NY Build your future at Curia, where our work has the power to save lives! Curia is a global ... matching contributions + Learning platform + And more! Summary The Senior Quality Assurance Validation Specialist assists with the validation activities… more
- Stantec (Boston, MA)
- Senior Commissioning/ Validation Specialist - ( 250000TF ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design ... group for an enthusiastic, diligent and experienced Commissioning / Validation Specialist . In this role you will prepare and implements project commissioning/… more
- SMBC (White Plains, NY)
- …Division to ensure continuous improvement of the model quality and governance. The Sr Model Validation Specialist applies numerical, statistical and ... of the Risk Management Department, the Model Risk & Validation department enhances the Model Risk Management framework for...qualitative knowledge to perform model validation and measures, monitors and reports model risk from… 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 ... standards such as 21 CFR Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:** + Planning and driving all CSV… more
- Boehringer Ingelheim (St. Joseph, MO)
- …in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Requirements for a Sr . Specialist Validation ** + A BS degree from an ... reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex validation… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key ... ensuring protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager, Validation Services, you will manage and coordinate installation,… more
- Discover (Riverwoods, IL)
- …interest rate, acquisition , macroeconomic models + Produce standardized model validation documentation, analytical reports and presentations for senior ... Description:** **What You'll Do** Responsible for auditing the model development and validation and related model risk management and governance functions in areas… more
- Fujifilm (College Station, TX)
- **Position Overview** The QA Specialist III, QA Validation , will be responsible for the review and approval of commissioning/qualification/ validation ... and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation , will handle all associated responsibilities in… more
- Fujifilm (Santa Ana, CA)
- …+ Process Engineering and Manufacturing Engineering experience beneficial. + Proficiency in Validation Specialist Level I and II functions. + Experience with ... The Sr . Validations Engineer will be responsible for performing validation activities related to processes, equipment, test methods, computerized systems, and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …IT application and template landscape. Takes active advises on setting up optimal validation strategies and ensures that all process and technical topics are fully ... implementation and operational phase, including KPIs and trend analysis. Recognition and derivation of necessary control measures including necessary escalations.… more
- Cognizant (Muskegon, MI)
- Sr /Lead CSV Specialist Cognizant Technology Solutions in LSMG is seeking for a Sr /Lead CSV Specialist who could join our team of Engineering ... plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will...will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …in more than 110 countries and regions. Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist . The Sr Quality Assurance Specialist ... validation documentation, and SOP / work instruction updates. Additionally, the Sr . Quality Specialist is responsible to uphold and improve quality… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr . Specialist 1, QC LIMS supports the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, ... corporate, and scientific guidelines. The Sr . Specialist 1, QC LIMS configures, validates...the site. This includes migration of static data, configuration, validation and working with colleagues to ensure successful setup… more
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