Computer System Validation
333 open positions
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Senior Quality Engineer, Validation↗ Advita OrthoGainesville, FL, US 1mo Senior Validation Engineer providing cross-functional support in V&V development, planning, and execution for medical device processes, materials, equipment, and methods.
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Data Center Team Pharmaceutical Project Manager↗ Johnson ControlsIrving, TX, US $115k–$115k1mo Day-to-day project lead for validated environment and laboratory construction projects (cleanrooms, biosafety cabinets, containment suites) ensuring compliance with IQ/OQ/PQ, data integrity, and regulatory expectations.
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Spclst, Operations MsdNLD - North Brabant - Boxmeer 1mo 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 Engineering Specialist II – Equipment Engineering ThermofisherMississauga, Canada $56k–$56k1mo Provide specialized validation knowledge to support operations and clients by completing protocols for equipment, processes, and new products, and reviewing finished reports.
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Sr QA Validation Specialist RegeneronLimerick $54k–$54k1mo 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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MES Engineer / Quality Engineer (Pharma)↗ Orka Lifescience Partners Pte. Ltd.Singapore, S00, SG 1mo Review and approve electronic batch records, worksheets, and logbooks for MES implementation in pharmaceutical manufacturing; support validation activities and system integration with enterprise systems.
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CQV Engineer (CIP System)↗ Envirodynamics Solutions Pte. Ltd.Singapore, S00, SG 1mo Engineering, commissioning, qualification, and lifecycle management of Clean-in-Place (CIP) systems in pharmaceutical and biopharmaceutical manufacturing facilities.
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Computer System Validation Lead for Cell & Gene Therapy↗ RocheMadrid, MD, ES 1mo Lead Computer System Validation (CSV) for digital solutions in Cell & Gene Therapy, ensuring compliance with GMP and regulatory standards.
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Senior Validation Engineer AmgenSingapore Manufacturing - Tuas 1mo Lead validation engineering for commissioning, qualification, cleaning validation, and lifecycle maintenance of manufacturing systems and equipment in a pharmaceutical facility.
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Validation Engineering Specialist II – Equipment Engineering↗ Thermo Fisher ScientificMississauga, ON, CA $56k–$56k1mo Provide specialized validation knowledge to support operations and clients by completing and reviewing protocols for equipment, processes, and new products.
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Quality Control Qualification Engineer↗ Coalesce Management ConsultingOutram, S00, SG 1mo Qualify environmental monitoring particle counters and laboratory computerized systems to ensure GxP compliance and data integrity.
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Validation Expert (m/f/d)↗ NovartisKundl, Tyrol, Austria $61k–$89k1mo Planning and execution of process and cleaning validation projects to ensure safe, high-quality pharmaceutical manufacturing.
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Validation Engineer, Sterility Assurance IntuitiveSunnyvale, CA, us 1mo 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↗ Jda Wms Pte. Ltd.Bugis, S00, SG 1mo Execute commissioning, qualification, and validation activities for GMP-regulated pharmaceutical and biopharmaceutical facilities, equipment, utilities, and computerized systems.
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CQV Engineer LonzaUS - Bend, OR 1mo Execute qualification protocols (IQ/OQ/PQ) and temperature mapping to ensure equipment and processes meet FDA/cGMP standards for drug manufacturing.
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RFD_Validation Analyst 1 PciservicesRockford, IL, USA $0k–$0k1mo Own validation projects for limited-risk biopharma customers, ensuring compliance with government and customer requirements through protocol generation, execution, and documentation.
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Senior IT Specialist, Regulatory Systems (Veeva RIM) | Remote↗ VantiveRemote 1mo Own and manage Regulatory applications (Veeva, TrackWise) ensuring compliance with GxP, 21 CFR Part 11, and CSV requirements in a Life Sciences environment.
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GxP Sr. Systems Engineer ModernaTXRemote - US $122k–$122k1mo Administer, configure, and validate Chromeleon CDS systems for laboratory informatics in a GMP environment.
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(Senior) Qualification / Validation Engineer (w/m/d)↗ BakerhicksRemote 1mo Execute qualification (DQ, IQ, OQ, PQ) and validation activities (process, cleaning, CSV) for pharmaceutical and medical device projects while ensuring compliance with cGMP regulations.
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CQV Engineer↗ Ips-Integrated Project ServicesDublin, County Dublin, Ireland 1mo Perform cGMP compliance-based services including commissioning, qualification, and validation for pharmaceutical, biotech, and animal health research and manufacturing facilities.
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Project Manager, CQV BarrywehmillerIndianapolis, IN 1mo 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 1mo 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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Coordinador/a de Validaciones CatalentBuenos Aires, Argentina 1mo Leading and developing the Validation team to ensure regulatory compliance, operational efficiency, and continuous improvement in a pharmaceutical manufacturing plant.
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Calibration & Validation Engineer - Temperature & Humidity (Medical)↗ Recruit Now Singapore Pte. Ltd.Yishun, S00, SG $5k–$5k1mo Calibrate and validate temperature and humidity instruments and systems to ensure accuracy and regulatory compliance in controlled environments.
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Principal Validation Engineer↗ ImmunitybioEl Segundo, CA, US $149k–$149k1mo Coordinate validation activities, prepare and execute protocols (IQ/OQ/PQ), and manage contractors for FDA-regulated biopharmaceutical equipment and systems.
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Computer System Validation Expert (all gender) AltenRemote 1mo Plan, execute, and document validation activities for computerized systems in the pharmaceutical industry to ensure regulatory compliance.
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CSV Engineer↗ Katalyst Healthcares & Life SciencesSan Francisco, CA, US 1mo Develop and implement validation strategies, documentation, and testing for computer systems and software applications to ensure regulatory compliance and system qualification.
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QC Equipment Qualification Engineer↗ Pqe Singapore Pte. Ltd.Singapore, S00, SG 1mo Plan, draft, and execute full lifecycle validation documentation (DQ, IQ, OQ, PQ) for QC laboratory instruments and ensure computerized systems compliance with 21 CFR Part 11 and Data Integrity principles.
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Senior Manager, IT Qualification & Validation↗ Arcus BiosciencesRemote $175k–$175k1mo Provide senior-level leadership and hands-on expertise in the qualification and validation of GxP-regulated computerized systems and IT infrastructure throughout the lifecycle.
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?Quality Assurance Validation Associate↗ Totowa, NJ, US 2mo Supports the development, execution, and documentation of validation protocols for equipment, manufacturing processes, and cleaning procedures to ensure compliance with quality and regulatory standards.
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Systems Performance Engineering Associate I↗ SterisOttawa, Ontario, Canada $62k–$62k2mo Ensure sterilization monitoring and control solutions are tested, configured, commissioned, and maintained through the product lifecycle, verifying new products and updates against quality standards at customer facilities.
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MES Validation Specialist (Electronic Batch Record)↗ Amaris Act Pte. Ltd.Tanjong Pagar, S00, SG 2mo Validate Electronic Batch Record (EBR) systems and support MES testing activities within GMP-regulated manufacturing environments.
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Validation - Lead Engineer - Project Farma↗ PerkinelmerRemote, US $95k–$95k2mo Lead Validation Engineer executing CQV and Computer System Validation (CSV) protocols for life sciences projects, ensuring compliance with FDA/GMP standards and delivering high-quality technical documentation.
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?Senior Analyst, Computer Systems Validation↗ Remote, US 2mo Senior individual contributor responsible for planning, authoring, coordinating, and executing risk-based validation and system lifecycle activities for computerized systems used in regulated GxP operations.
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Production Planning Model Validation Engineer ExxonMobilKuala Lumpur, MY 2mo 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 2mo Implement Veeva Quality suite (QMS, QualityDocs, Training, Validation, LIMS) for life sciences customers to modernize quality management and ensure compliance.
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CSV Manager ViatrisInverin, County 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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Principal Engineer Quality MedlineShanghai 上海 2mo 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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Analista de Validação SyntegonValinhos, SP, br 2mo Develop, execute, and report on equipment and utility qualification/validation plans for pharmaceutical manufacturing units.
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Senior CSV Engineer↗ CognizantCork, County Cork, Ireland 2mo Validate lab computer systems and instruments in QCL Labs and Manufacturing Operations to ensure compliance with GMP and regulatory standards.
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Senior Quality Engineer - Validation↗ West Pharmaceutical ServicesDublin, County Dublin, Ireland $65k–$65k2mo Ensure compliance with FDA regulations (QSR, cGMP), ISO 13485, and customer specifications for New Product Introduction (NPI) projects in the medical device/pharmaceutical sector.
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