- Merck & Co. (Rahway, NJ)
- …Plant MaintenanceExperience with ProCal as the Computerized Calibration Maintenance System (CCMS).Sanitization and sterilization validation (SIP, autoclaves, ... Job DescriptionPosition Description: Specialist , Sterile Engineer This Sterile Pharm Operations Engineer position will provide engineering support to sterile… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the ... requires close collaboration with various teams including Production, Quality Assurance, Validation and Facilities, as well as external resources, when necessary, to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist , Equipment Management as part of the Quality team based in Raritan, NJ. ... Role Overview The QC Specialist , Equipment Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration. Key… more
- Merck & Co. (Rahway, NJ)
- …projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Specialist - ... Automation include the following:Site Operations (GWES) :- The Automation specialist will help to support several automation systems...well as the vendor to ensure that the computer system operation and computer system validation… more
- BioAgilytix (Durham, NC)
- …file permission settings as it pertains to data integrity and computer system validation .Detail oriented and highly organizedExcellent oral and written ... therapeutics to the patients who need them.The Senior Laboratory Automation Specialist will be primarily responsible for leading the programming and implementation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a CQV Specialist (Contract Position) as part of the Technical Operations team based in Raritan, ... This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …write up Deviations events utilizing Root Cause Analysis Utilize the quality system to implement changes associated with technical operations, engineering, and/or ... validation (generate, execute, and evaluate change requests) Revise and...records, reports) associated with technical operations, production, engineering, and validation Incorporate technical pre-planned process improvements and cost reduction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to 340B Policy Regulation restrictions Research 340B customers through the external/internal systems to ensure eligible customers will have access to 340B contract ... aligns with and is synchronized to Novo Nordisk data systems Execute contract data testing with IT and testing...instructions and procedures Verify contract membership data testing and validation with IT is properly performed Work with Chargeback… more
- Merck & Co. (Durham, NC)
- …in accordance with Computer Software Assurance (CSA)Lead the definition, SDLC documentation and validation of new master data and system parameters as a member ... of a team responsible for new products/MBR's.Lead the definition, SDLC documentation and validation of master data and system parameters changes required for MES… more
- BioAgilytix (Boston, MA)
- …perform responsibilities of a traditional lab analyst, peer reviewer, and new system implementation specialist . Tasks will encompass running assays, reviewing ... a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging...automation; liaise with all parties to promote adoption of systems for increased efficiency Creates and manages system… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process ... therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered… more
- Regeneron Pharmaceuticals (Troy, NY)
- …company manufacturing standards policies and procedures. The day to day of a QA Validation Specialist could include, but are not limited to, the following: + ... processes for improved performance + Knowledge using in thermal validation systems (Kaye Validators) is preferred To...of relevant experience for each level: + Associate QA Validation Specialist : 0 - 2 years… more
- Regeneron Pharmaceuticals (Troy, NY)
- …safely deliver medicine to the patients. The day to day of an Associate QA Validation Specialist could include, but are not limited to, the following: + ... Sciences and the following years of relevant experience for each level: + Assoc. QA Validation Specialist : 0 - 2 years + QA Validation Specialist : 2+… more
- United Therapeutics (Silver Spring, MD)
- …diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently ... teams + Develop and execute protocols and summarize reports supporting the validation of equipment, systems , and processes, as needed. Participate in… more
- PCI Pharma Services (Philadelphia, PA)
- …duties and responsibilities include the following but other duties may be assigned. A Validation Specialist is expected to lead the business beyond the normal ... opportunities within existing business or customer requests Standardization/harmonization/streamlining of validation activities. A Validation Specialist will… more
- University of Washington (Seattle, WA)
- …of Laboratory Medicine and Pathology has an outstanding opportunity for a **Computer Systems GxP Validation Specialist ** **WORK SCHEDULE** + 40 hours ... Part 11 compliance. + Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems . + Excellent… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify ... the validation / qualification procedures and policies. Maintains protocols and system documentation in an orderly library so that information can be provided… more
- Catalent Pharma Solutions (Princeton, NJ)
- **Position Title:** ** Validation Specialist ** M-F 1st shift **Summary:** _In this critical position,_ **_the Validation Specialist_** _is responsible for ... and current industry practices_ **The Role:** + Generate and execute Validation protocols (IQ/OQ/PQ) of site equipment including production equipment, utilities (as… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Sr. Validation Specialist , Pharmaceuticals- Monroe, NC (MULTIPLE-POSITIONS AVAILABLE) Department: Validation Location: Monroe, NC START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3032926&source=3032926-CJB-0) Glenmark is actively seeking a Senior Validation Specialist to join the growing team… more
- System One (Groton, CT)
- Job Title: Quality Validation Specialist Location: Groton, CT Hours/ Schedule: Monday -Friday, 1st Shift schedule. Type: Contract Responsibilities + Provide ... and related utilities (eg, water, nitrogen, etc.). + Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ,… more
