- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy ... product to patients.Key Responsibilities Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages… more
- Fujifilm (Holly Springs, NC)
- …Requirements** * Prior experience and working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl and/or Kneat validation software. * Basic experience ... from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other… more
- Fujifilm (Holly Springs, NC)
- …in Life Sciences or Engineering * Working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl and/or Kneat validation software * Understanding of cell ... processes, through operational readiness, as well as provide oversight of validation program execution for these processes. This role will also collaborate… more
- Fujifilm (Holly Springs, NC)
- …Part 11 **Preferred Requirements:** * Working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl and/or Kneat validation software * Understanding of ... and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports *… more
- Fujifilm (Holly Springs, NC)
- …**Preferred Requirements** * Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation software, TrackWise is preferred * Experience and understanding ... experience in GMP Quality Assurance and/or similar role * Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA regulated… more
- Fujifilm (Holly Springs, NC)
- …skills **Preferred Requirements** * Working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl and/or Kneat validation software is a plus ... utilities, quality systems, automation, manufacturing & IT Systems, and/or validation methodologies * Understanding of GAMP5, Data Integrity, and application… more
- Fujifilm (Holly Springs, NC)
- …Life Sciences or Engineering * Working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl and/or Kneat validation software * Understanding of ... utilities, quality systems, automation, manufacturing & IT Systems, and/or validation methodologies * Understanding of GAMP5, Data Integrity, and application… more
- Fujifilm (Holly Springs, NC)
- …in a GMP environment **Preferred Requirements:** * Working knowledge of Smartsheet, Trackwise , MasterControl, Veeva and/or Kneat validation software is a plus ... cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation , and various Client functions to ensure Quality objectives and… more
- Novo Nordisk (Bloomington, IN)
- …Novo Nordisk and help us make what matters. The Position The validation department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System ... Validation (CSV). The equipment/facility team initially qualifies and maintains...to learn and use quality management software such as TrackWise (R) or ComplianceWire(R) + Ability to understand and independently… more
- Novo Nordisk (Bloomington, IN)
- …A Validations Technician's primary duty is to participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical ... computer systems, manufacturing processes and laboratory documentation, assisting validation engineers or performing tasks independently. Relationships Reports to:… more
- Novo Nordisk (Bloomington, IN)
- …Novo Nordisk and help us make what matters. The Position The Validation Department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System ... Validation (CSV). The equipment/facility team initially qualifies and maintains...to learn and use quality management software such as TrackWise (R) or ComplianceWire(R) + Ability to understand and independently… more
- Boehringer Ingelheim (St. Joseph, MO)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation … more
- Catalent Pharma Solutions (Madison, WI)
- **Senior Engineer I, Validation ** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... of doses of life-enhancing and life-saving treatments for patients annually. The Validation group has oversight of the validation program, including… more
- Integra LifeSciences (Princeton, NJ)
- …professional with complete and in-depth conceptual and practical knowledge of Trackwise Digital platform. The candidate will lead delivery of system improvements ... and analyzing impacts on the existing solution * Applying knowledge of Trackwise 's best practices to internal processes to make recommendations for system design.… more
- Fujifilm (Holly Springs, NC)
- …Part 11 **Preferred Requirements:** * Working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl, Veeva, SAP, and/or Kneat validation software * ... and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports *… more
- Novo Nordisk (Bloomington, IN)
- …manufacturing and release of bulk drug substance and drug product. Method Validation : Analytical testing, data analysis, document writing, and data reporting to ... support phase appropriate method validation of analytical methods. These methods directly support the...complexity of the investigations. + Utilize investigation management system ( TrackWise ), data analysis tools, or other relevant technologies. +… more
- Honeywell (IL)
- …MES, EDMS and QMS) + Experience with implementing QMS, documenting validation plans and conducting customer workshops ABOUT HONEYWELL Honeywell International Inc. ... on Sparta. Sparta Systems, a Honeywell company, is a leading provider of TrackWise (R) enterprise QMS software and TrackWise Digital(R), a next-generation, cloud… more
- Novo Nordisk (Bloomington, IN)
- …Assist with the development, execution and approval of System and Validation Lifecycle Documentation for site GxP systems, including specifications, test protocols, ... and various assessments. + Complete review and approval of Computer System Validation documents in the EDMS system. + Develop and implement administrative procedures… more
- Kelly Services (Parsippany, NJ)
- …and Technical Support - Parsippany NJ** **Job Title: Quality System Lead - Validation & Compliance** **Summary:** The Quality System Lead will be responsible for ... reviewing and overseeing various validation and qualification documentation, including but not limited to,...+ Direct working knowledge of quality systems such as Trackwise , LIMS, EBRs, Oracle, or similar platforms. + At… more
- Integra LifeSciences (Princeton, NJ)
- …Plan, Requirements Traceability Matrix, Clinical Evaluation Report (CER), Design and Verification/ Validation studies and Process Validation studies. + Coordinate ... development documentation such as product requirements, schematics, verification, and validation strategy/execution. + Coordinate, review and approve development documentation… more
