- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + Performs ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more
- Lilly (Indianapolis, IN)
- …IT support to end-users and addressing their needs promptly. + Maintain computer system validation for responsible applications. + Deliver recommendations to ... time-sensitive situations. **Basic Requirements:** + Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related field. +… more
- Guidehouse (Mclean, VA)
- …cleaning, data transfers, data quality control, data integration and validation , data analysis and report package preparation, statistical simulation, statistical ... biology, biochemistry, microbiology or similar), or physical science (engineering, physics, computer science, or similar) + **OR** **Post graduate degree in**… more
- Cardinal Health (Phoenix, AZ)
- …electrical, mechanical, and control domains. + Develops detailed 3D CAD ( Computer Aided Design) models, engineering drawings, and assembly documentation. + ... senior engineers. + Participates in prototype fabrication and testing, using CNC ( Computer Numerical Control) machining and additive manufacturing tools as needed. +… more
- ThermoFisher Scientific (Greenville, NC)
- …sites. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess ... detail, process and prioritize sensitive complex information + Proficiency in basic computer applications + Fluent in spoken and written English + Excellent… more
- Medtronic (Minneapolis, MN)
- …develop robust implementation strategies and rigorous verification and validation mechanisms. Proactively engage with cross-functional development teams, prepare ... security frameworks, architectures for connected systems. Experiences in medical devices, FDA guideline and international standards (eg NIST, ISO/IEC 27001, MITRE… more
- Cambrex High Point (High Point, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... + Maintain a clean and safe work-space + Maintain laboratory notebook and/or computer files (ie LIMS) according to standard, accepted practices + Participate in… more
- PCI Pharma Services (Rockford, IL)
- …for line improvements monthly. Provide information on product contact materials and validation support weekly. + Attend and support customer conference calls weekly. ... **Must have a minimum of at least three years of experience in an FDA -regulated industry with a strong preference for medical devices or combination products** . +… more
- PCI Pharma Services (Philadelphia, PA)
- …eligible to apply for open positions._** **Preferred:** + Strong knowledge of cGMP, FDA regulations, and validation principles. + Experience in a CDMO ... knowledge of process engineering principles and practices. + Intermediate Computer Skills: Ability to perform more complex computer... Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer… more
- Bristol Myers Squibb (Devens, MA)
- …their work + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves complex ... requirements. **Knowledge, Skills, Abilities:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more