Catalent: Global provider of drug development and manufacturing solutions.
5+ YOEBachelor’s degree in business, computer science, data science, or related field; 5+ years of data integration delivery experience; IDMC, iPaaS, and API expertise required.
Informatica Data Management Cloud (IDMC), IICS, Integration Platform as a Service (iPaaS), Application Program Interfaces (APIs), Microsoft Azure Data Factory, Databricks, SAP Ariba Supply Chain Collaboration Network, TraceLink, E2Open, OneNetwork, Web Services, ETL
Fujifilm SonositeTokyo Stock Exchange: 4901: Develops portable ultrasound systems for point-of-care medical diagnostics.
5+ YOELead LIMS architecture, configuration, validation, and governance; ensure GMP compliance and data integrity; 5+ years analytical laboratory experience and a relevant science degree required.
LabWare LIMS, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
FujifilmTokyo Stock Exchange: 4901: Provider of diagnostic imaging and healthcare technology solutions.
0+ YOEBachelor’s in Life Sciences/Engineering with 2 years experience OR Master’s with no experience; 1-3 years GMP experience; validation and quality oversight in FDA-regulated facilities; knowledge of GAMP5, data integrity, and 21 CFR requirements.
ASTM E2500, Smartsheets, Trackwise, Veeva, Kneat, GAMP5, 21 CFR Part 820, 21 CFR Part 11
VidendumLondon Stock Exchange: VID: Manufacturer of professional equipment for image capture and content creation.
Proven experience with IFS in a finance systems role, strong understanding of GL/AP/AR/fixed assets/intercompany, ERP configuration, data migrations/integrations, data governance, testing, training, and stakeholder communication.
Senior Specialist 2, Quality Control Instrumentation
Holly Springs, North Carolina, United States
OnsiteFull Time
Fujifilm SonositeTokyo Stock Exchange: 4901: Develops portable ultrasound systems for point-of-care medical diagnostics.
3+ YOEBachelor's/Master's/PhD in chemistry/biological sciences/engineering with 3+ years GMP experience; hands-on with analytical instrumentation, SOP authoring, data integrity, CAPA and quality systems.
UPLC/HPLC, Capillary Electrophoresis, Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis, Western Blot, Plate Reader, qPCR, Spectrophotometry, Mass Spectrometry, Customer Relationship Management, KNEAT
Sr/Principle Computer Systems Validation Specialist
Durham, North Carolina, United States
$118k-$184k/yrOnsiteFull Time
KBI Biopharma: Contract development and manufacturing for biopharmaceutical companies.
8+ YOESenior/Principal level CSV expertise in cGMP, data integrity, 21 CFR Part 11, FDA-regulated manufacturing; 8+ to 15+ years experience; based in NC; GMP compliance knowledge.
8+ YOEBachelor's degree in a scientific or technical discipline; 8–10 years in GxP and 4 years leading quality projects. Requires GxP, FDA, EMA, ICH, ISO, QRM, data integrity, and sterile manufacturing expertise.
Kyowa KirinTokyo Stock Exchange: 4151: Researches and manufactures pharmaceutical therapies for rare and intractable diseases.
5+ YOEBachelor's degree or equivalent experience; 5+ years managing LMS systems and instructional design in a regulated industry; Veeva LMS, GMP, data integrity, reporting, system administration, and communication expertise.
Veeva Vault Training, Articulate Storyline, Rise, Camtasia, Veeva, Microsoft Office Suite, Articulate 360, Captivate, Canva, Learning Management Systems (LMS)