- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... , and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment,… more
- Twist BioScience (South San Francisco, CA)
- …11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ ... DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and... (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS,… more
- BioAgilytix (Durham, NC)
- …visibility into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA , EMA, or ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Aequor (Hicksville, OH)
- …experience in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient ... upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels...and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is… more
- Eisai, Inc (Nutley, NJ)
- …Oracle, SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong ... software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... including audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and… more
- Aequor (Cincinnati, OH)
- …Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data ... COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer… more
- Validation & Engineering Group Inc. (Raleigh, NC)
- …to and with expertise in the following areas: Process Equipment and Utilities IQ/OQ Computer System Validation (CSV) Experience with the qualification of ... and Medical Devices industries in the following areas: Laboratory, Compliance, Computer , Engineering, Project Management, Validation , and other services. We… more
- Actalent (Winston Salem, NC)
- …projects as assigned by management. Essential Skills Engineering, quality assurance, quality system , validation , systems engineering. Understanding of full ... regulatory expectations and best practices related to data integrity and computerized system validation . Foster effective working relationships with internal and… more
- Cencora (Albany, NY)
- …of reviewing and writing technical documents such as risk assessments and validation documents Strong knowledge of cGMP/ FDA regulations Strong communication ... with GMP standards by developing, executing, and documenting cleaning validation activities in a pharmaceutical manufacturing environment. This role collaborates… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …standards. Requirements: 5-8 years of experience in Computer System Validation (CSV). Strong knowledge of FDA regulations and GAMP5. Hands-on experience ... Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7… more
- Katalyst HealthCares and Life Sciences (Alviso, CA)
- …room environment experience. Experience with Test Method Validation and/or Measurement System Analysis is preferred. A knowledge of computer software for the ... (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation , and Production. Validation of test methods....packages (Minitab preferred), is a plus. Demonstrated understanding of FDA Quality System Regulation (21 CFR 820)… more
- Cardinal Health (Indianapolis, IN)
- …systems including manufacturing equipment, laboratory instrumentation, utilities, spreadsheets, and computer systems . Develop and/or review master level plans ... guidance to local project teams on a range of validation and qualification initiatives to ensure existing systems...Engineering or a Physical Science. 5+ years of relevant validation experience preferred. Knowledgeable in FDA or… more
- Sharp Services (Allentown, PA)
- …of all validation activities related to equipment, process, facilities and computer systems as required. Validation activities will be performed ... limited to packaging, cleaning, HVAC and computer system . Participate in customer audits specific to validation...Six Sigma, etc.) is required Broad knowledge of current validation principles and industry practices, including FDA … more
- Grand River Aseptic Manufacturing (Grand Rapids, MI)
- … of cGMP equipment, facilities and processes. These duties will include validation of laboratory systems , production equipment, manufacturing processes, and ... cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations. Proficient computer skills in Microsoft… more
- Katalyst HealthCares and Life Sciences (Rensselaer, NY)
- …coordination between cross functional teams within at least one area of systems validation - eg, laboratory equipment, facilities, utilities, manufacturing ... and provide guidance through all stages of the quality management system and improvement projects. Ensures new systems /processes/procedures are compliant… more
- Cedars Sinai (Los Angeles, CA)
- …with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems . Prepares project reports ... and local agencies, including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Primary Duties and...studies, including processing clinical data using a range of computer applications and database systems to support… more
- VTI Life Sciences (San Diego, CA)
- …of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... Scripts. 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation ....Software Validation and Computerized Systems Validation . Must have experience working in an FDA… more
- Revolution Medicines (Redwood City, CA)
- … (eg, Word, Outlook, Excel, PowerPoint, Visio, etc.). Preferred Skills: Good knowledge of Computer System Validation . The base salary range for this ... with respect to RevMed's Standard Operating Procedures, applicable regulatory requirements ( FDA , EU, ICH & country-specific), and current industry standards and… more
