- 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
- Insight Global (Parsippany, NJ)
- …and final handover of documents to Operations with minimal supervision. Complete TrackWise deviations and qualification / validation deviations related to ... Job Description Insight Global is seeking a Validation Specialist to support a large pharmaceutical client....(IQ, OQ, PQ) Experience with CAPAs, deviations and utilizing TrackWise QMS Bachelor's Degree in Engineering or related discipline… 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)
- …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
- Actalent (Sellersville, PA)
- …and stability samples. + Support QC Systems Admin activities (Empower, LIMS, Trackwise ). + Prepare and review validation /verification protocols. + Train ... analysts. + Lead laboratory OOS and OOT investigations. Essential Skills + Proficiency with HPLC, GMP, and dissolution testing. + Experience with HPLC/Empower 3, UPLC, GC, and wet chemistry. + Bachelor's degree in chemistry, biology, microbiology, or other… more
- Actalent (North Billerica, MA)
- …team members. Understand and have experience with QMS systems, such as TrackWise . Review and approve protocols, validation documents, investigations, and ... team members + Understand and have experience with QMS systems, such as TrackWise + Review and approve protocols, validation documents, investigations, and… 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
- 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
- Novo Nordisk (Bloomington, IN)
- …Join Team Novo Nordisk and help us make what matters. The Position A validation technician's primary duty is to participate in validation projects relating to ... critical computer systems, manufacturing processes and laboratory documentation, assisting validation engineers or performing tasks independently. Relationships Reports to:… 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
- 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
- Integra LifeSciences (Princeton, NJ)
- …of information. + Understands business challenges, provides recommendation on Trackwise functionalities to cover the Quality processes (CAPA, Audit, Complaint, ... Works to build consensus within cross functional project teams. + Shares their Trackwise expertise with support team and business Subject Matter experts. + Leads… more
- AbbVie (Waco, TX)
- …justification of nonconforming events, method validations, and prepares Laboratory/ Validation reports. Requires knowledge and technical expertise of Microbiology, ... regulatory requirements and Global TrackWise system. Responsibilities + Responsible for QC lab investigations....supports method validations and prepares final reports documenting the validation findings. + Receives and interprets the results of… 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
- 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
- Sanofi Group (Northborough, MA)
- …reviewing/approval of production records and related support documents, validation study review/approval, SOP review/approval, finished product inspection, ... approved product specifications and market regulations + Reviewing and approving validation protocols and change controls + Authoring, revising and reviewing SOP's… more
- IQVIA (Mooresville, NC)
- …of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in general. + Evaluate audit ... etc. to ensure IQVIA meets or exceeds industry best practices for compliance and validation . + Collaborate with other IT members, QA, and business functions on … more
- Novo Nordisk (Bloomington, IN)
- …guidance and execution on facilities and equipment projects + Support Maximo/ Trackwise (CM/CMR/CC) workflow + Develop standard processes to evaluate future capital ... team + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities + Manage… more
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