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
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.
GuerbetEuronext Paris: GBT: Provides contrast media and medical devices for diagnostic imaging.
Associate degree or technical training in microbiology/biology/biotechnology, experience in GMP/sterile manufacturing, environmental/utilities sampling, cleanroom aseptic techniques, and familiarity with LIMS and data integrity practices.
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)
North Carolina Education Lottery: Operates lottery games to raise money for North Carolina education.
5+ YOEAssociate's degree with 5+ years relevant experience (Bachelor's preferred); background in investigations/risk/law enforcement; strong data analysis, report writing, and judgment; proficiency in Power BI, Microsoft Excel, and Outlook.