Computer System Validation
595 open positions
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Quality Validation Engineer AbbottIreland - Kilkenny 2mo Creating and maintaining validation documentation for new and existing systems, processes, equipment, facilities, and software used in the manufacture, control, and storage of medical devices.
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Transformation Project Qualification Lead- API AbbVieNorth Chicago, IL, us 2mo Lead project teams to drive schedule, execution, risk management, and reporting for commissioning, qualification, and validation of new/modified equipment, facilities, utilities, and processes in line with project and quality objectives.
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Berufseinsteiger Qualifizierungsingenieur / Qualifizierungstechniker (m/w/d), Binzen Pharmatronic GmbHBinzen, Kreis Lörrach, BADEN_WUERTTEMBERG 2mo Supporting, organizing, and executing GxP-compliant qualification and validation tasks for investment projects involving pharmaceutical production, laboratory, and infrastructure systems.
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Specialist QA CSV (Computer System Validation) (m/w/d) Simtra Deutschland GmbHHalle (Westfalen), NORDRHEIN_WESTFALEN 2mo Specialist responsible for planning, executing, and continuously improving Computer System Validation (CSV) and Computer Software Assurance (CSA) for IT systems, applications, and databases in a GMP-regulated pharmaceutical manufacturing environment.
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Business Systems and Validation Analyst III ThermofisherHighland Heights, Kentucky, USA 2mo Validating laboratory instrumentation and computerized systems in accordance with regulatory expectations (EMA guidelines) and internal quality standards.
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Computer Systems Validation Engineer PraxisprecisionmedicinesRemote $150k2mo Lead Computer System Validation strategy and operations for GxP technology portfolios in a biotech company, ensuring compliance and data integrity while scaling validation capabilities.
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QC Validation Specialist MeiragtxLondon / Shannon 2mo Validation and technology transfer of analytical test methods for gene therapy products and associated materials to ensure compliance with EU and FDA GMP requirements.
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Senior Engineer Validation StrykerGurugram, India 2mo Execute validation activities (IQ/OQ/PQ) to industrialize and transfer new medical device products into manufacturing, ensuring compliance with regulatory standards.
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QA Engineer VwrHillegom, NLD 2mo Ensure new processes, equipment, and products are introduced in compliance with quality and regulatory requirements for manufacturing expansion.
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IT Quality & Validation Specialist↗ Hikma PharmaceuticalsSintra, Lisbon, Portugal 2mo Execute Computer System Validation (CSV) for GxP systems, ensuring compliance with regulations like 21 CFR Part 11 and Annex 11 for Hikma's injectable pharmaceutical production.
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CSV Manager↗ ViatrisCounty Galway, Ireland 2mo Manage end-to-end Computerized System Validation (CSV) for GxP computerized systems to ensure regulatory compliance and maintain validated states.
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Testovací inžinier pre HMI a PLC (Alarm & Function Testing) (m/ž) SyntegonRemote 3mo Perform Alarm & Function, PLC, and HMI testing for pharmaceutical production lines in compliance with GMP standards.
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Quality Engineer I BaxterCleveland, Mississippi $76k3mo Ensure quality and reliability of healthcare products through process validation, control studies, and regulatory compliance.
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Validation Engineer II (Medical Industry)↗ Bepc Inc. - Business Excellence Professional ConsultingCiudad Juárez, Chihuahua, Mexico 3mo Develop and execute IQ, OQ, and PQ validation protocols for manufacturing and medical device environments to ensure regulatory compliance.
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Qualification Officer (m/w/d) - Quality Assurance↗ Octapharma AustriaVienna, Vienna, Austria €52k3mo Ensure GMP compliance and lead qualification projects for pharmaceutical manufacturing equipment and processes.
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Spclst, Operations MsdNLD - North Brabant - Boxmeer 3mo Senior Validation/Qualification Engineer coordinating, executing, and reporting validations, qualifications, and calibrations for multiple locations to ensure product quality and safety.
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Validation Expert (m/f/d)↗ NovartisKundl, Tyrol, Austria €61k–€89k3mo Planning and execution of process and cleaning validation projects to ensure safe, high-quality pharmaceutical manufacturing.
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Sr QA Validation Specialist RegeneronLimerick €54k3mo Supervise end-to-end qualification processes for equipment to ensure fit-for-purpose and support inspection readiness in a highly regulated manufacturing environment.
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Validation Engineer, Sterility Assurance IntuitiveSunnyvale, CA, us 3mo Support sterilization processes for single-use surgical instruments and accessories, ensuring safety and efficacy through bioburden testing and compliance.
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Validation Engineer Trainee - Attach & Train program↗ RocheSingapore, Singapore 3mo Maintain site Right to Operate and enable manufacturing excellence by providing validation support for safe, high-quality production in a GMP biotech contract manufacturing facility.
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(Senior) Qualification / Validation Engineer (w/m/d) BakerhicksRemote 3mo Proactive expansion of the Qualification & Validation business area, executing DQ/IQ/OQ/PQ and Process/Cleaning/CSV validation activities under cGMP regulations.
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Technischer Assistent (m/w/d) Team Labormanagement Richter BioLogics GmbHBovenau, SCHLESWIG_HOLSTEIN 3mo Planning, coordinating, and executing maintenance, calibration, and validation of laboratory equipment and computerized systems according to GMP standards.
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Project Manager, CQV BarrywehmillerIndianapolis, IN 3mo Lead validation projects for life sciences clients, ensuring compliance with FDA regulations and delivering commissioning, qualification, and validation solutions.
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Senior Validation or Validation SME for new filling line project (Osaka Plant) TakedaOsaka (Juso), Japan 3mo Develop and execute validation strategies for a new filling line project involving liquid/powder filling, sterilization, and cleaning equipment at the Osaka plant.
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Computer System Validation Expert (all gender) AltenRemote 3mo Plan, execute, and document validation activities for computerized systems in the pharmaceutical industry to ensure regulatory compliance.
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Principal Validation Engineer PfizerUnited States - Massachusetts - Andover $124k3mo Principal owner of the Pfizer Andover site validation program and master plan, ensuring compliance and effectiveness for biologics drug substance/drug product production, testing, storage, and transport.
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Spezialist (m/w/x) Reinigungsvalidierung Pharma Artesan Pharma GmbH & Co.KGLüchow (Wendland), NIEDERSACHSEN 3mo Planning, executing, and documenting cleaning validations for production equipment and media systems in solid dosage pharmaceutical manufacturing.
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Validation Engineer CryoportIrvine, California $120k3mo Client-facing Validation Engineer supporting shipper, packaging, and shipping lane qualifications for temperature-sensitive supply chains in life sciences.
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Production Planning Model Validation Engineer ExxonMobilKuala Lumpur, MY 3mo Validate and optimize production planning models for crude and feedstock purchasing and run plan signals in petrochemical plants.
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Consultant - Quality Systems Implementation VeevaChina - Suzhou 3mo Implement Veeva Quality suite (QMS, QualityDocs, Training, Validation, LIMS) for life sciences customers to modernize quality management and ensure compliance.
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Principal Engineer Quality MedlineShanghai 上海 3mo Act as a Subject Matter Expert for validating medical device manufacturing equipment, sterile packaging, water systems, and cleaning processes to ensure compliance with regulatory standards.
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Valideringsingenjör / Validation Engineer inom Life Science↗ QriosStockholm, Stockholm County, Sweden 3mo Validation and qualification of equipment, processes, or computerized systems in regulated environments.
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Senior Specialist, Associate Aseptic Process Validation Engineer BristolmyerssquibbDevens - MA - US $88k3mo Supports the execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications for the Devens Cell Therapy Facility.
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Sachbearbeitung Validierung Herstellung (m/w/d) G. Pohl-Boskamp GmbH & Co. KGHohenlockstedt, SCHLESWIG_HOLSTEIN 3mo Conducting qualification of machines, rooms, and media systems (water, compressed air, ventilation) and supporting process and cleaning validations with testing and sampling.
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Validation Engineer II EmpowerpharmacyHouston, TX 3mo Drives compliance and manufacturing readiness across sterile and non-sterile operations through equipment, process, and computer system validation.
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Qualification & CSV Specialist | Freelancer SgsLisboa, Lisboa, pt 3mo Execute equipment, facility, and system qualification and computerized system validation (CSV) activities for pharmaceutical, biotech, and medical device projects.
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Tecnico di Convalida – Calibratore Pharma Veolia Environnement SAVerona, Veneto, it €25k–€32k4mo Execute technical qualification, validation, and calibration of instruments and equipment within pharmaceutical production processes.
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IT-Spezialist / Systemadministrator (m/w/d) Pharma & Gebäudeinfrastruktur Paul W. Beyvers GmbHBerlin, BERLIN 4mo IT specialist and system administrator responsible for IT administration, computer system validation (CSV), quality assurance (GMP) support, and building infrastructure management in a pharmaceutical manufacturing environment.
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Computer Systems Validation Engineer LonzaUS - Portsmouth, NH 4mo Identify and implement industry best practices for computer systems validation (CSV) in biotech/pharma manufacturing, ensuring compliance with regulations like 21 CFR Part 11 and GAMP.
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Manager, CSV Cell Therapy BmsSummit West - NJ - US 4mo Manager leading equipment and computerized system qualification, validation, and lifecycle management for CSV (Computerized Systems Validation) in cell therapy manufacturing and laboratory environments.
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Chargé AQ Validation des systèmes informatisés / Data Integrity Officer - F/H (CDI) PolyPeptide FranceStrasbourg, FR 4mo Ensure compliance with regulations (GMP, 21CFR Part 11, Annex 11) and group/local procedures for computerized system validation and data integrity at the Strasbourg site.
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