2+ YOESME for CMMS/Maximo, document control, change control, CAPEX and purchasing support, CMMS reporting and audits, SOP and archival maintenance for manufacturing/utility operations.
2+ YOECreate and revise manufacturing documents (BPRs, SOPs, CCRs), perform manufacturing investigations and CAPA activities, use SAP/SAP QM, act as SME for documentation systems; programming experience (math.js, Java, PASX) strongly preferred; BS/BA and 2–5 years related experience.
6+ YOEBS/BA in a relevant field plus 6 years related experience (or equivalent). Experience in label development, regulatory/technical documentation, strong communication, and proficiency with Microsoft Word, Excel, Open Site Master and WebCenter.
Microsoft Word, Microsoft Excel, Open Site Master, WebCenter
Senior Specialist, Manufacturing Technical Support
Durham, North Carolina, United States
$109k-$202k/yrOnsiteFull Time
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
7+ YOEBachelor's in Engineering or Life Sciences,7+ years in biopharmaceutical GMP manufacturing,knowledge of FDA/GMP,QbD and Six Sigma,experience with deviations,CAPA and technical documentation,ability to travel up to 20%.
Technical Support Specialist - Metabolomics Kits (Europe)
United Kingdom or Germany or Research Triangle Park
RemoteFull Time
Metabolon: Provides metabolomics analysis services for life sciences research.
3+ YOEBachelor's in a life science,3+ years relevant lab/technical support experience,experience with LC-MS and metabolomics,ability to support customers remotely and create support documentation,knowledge of major LC/MS platforms and case management tools.
Integrated Bioinformatics Platform (IBP), Salesforce Service Cloud, Microsoft Teams, Xcalibur, MassHunter, Analyst, MassLynx, Thermo Fisher, SCIEX, Agilent, Waters
Senior Technical Specialist, Engineering and Facilities
Durham, North Carolina, United States
$140k-$185k/yrOnsiteFull Time
Beam TherapeuticsNASDAQ: BEAM: Develops precision genetic medicines using base editing technology.
12+ YOE12+ years biotech/GMP engineering experience with technical writing, lifecycle documentation, CAPA/ECC management, validation knowledge, and strong cross-functional communication.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheets, Veeva QDocs, Veeva QMS, Kneat, DeltaV (PCS), Disego (BAS), OSI PI, BlueMountain RAM / CMMS
Senior Specialist, Manufacturing Technical Support
Durham, North Carolina, United States
$109k-$202k/yrOnsiteFull Time
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global pharmaceutical developing and manufacturing medicines and therapies.
7+ YOEBachelor's in Engineering or Life Sciences,7+ years biopharmaceutical GMP manufacturing experience,strong GMP/ FDA knowledge,documentation and investigation experience,ability to travel up to 20%.
CM Mission Critical Engineering: Provides electrical and mechanical engineering for mission-critical facilities.
3+ YOEBachelor’s degree in mechanical engineering or related discipline, 3+ years of CFD or building mechanical systems experience, and proficiency with CFD software, programming, technical documentation, and presentations.
Cadence, FloEFD, Tileflow, Microsoft Office, STAR-CCM+, Fluent, FDS, OpenFOAM, 6SigmaRoom, Python, C++, Java, User Defined Functions (UDFs)
BaxterNew York Stock Exchange: BAX: Develops and manufactures medical devices, pharmaceuticals, and IV solutions.
10+ YOEBachelor's or Master's in CS/Software Engineering, 10+ years software development with embedded systems and Qt Studio, Jenkins CI/CD and Git experience, strong knowledge of medical-device regulatory standards and software documentation.