- 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)
- …records. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... in close proximity to strong magnets. + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. **Basic… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
- J&J Family of Companies (Danvers, MA)
- …and system monitoring **Qualifications:** + Bachelor's or Master's in Computer Science, Electrical/ Computer Engineering, or Embedded Software Engineering. ... for mechatronics products. + Experience with contract manufacturing, PCB design/ validation , and lab equipment. + Experience with in-circuit emulators, JTAG… more
- Novo Nordisk (Clayton, NC)
- …standards + Manage individual training plan + Participate in qualification & validation activities as required + Setup, operate, monitor, & control highly automated ... experience preferred + Minimum two (2) years of manufacturing experience in FDA regulated environment preferred + Experience demonstrating a systematic approach to… more
- Bristol Myers Squibb (Devens, MA)
- …Specific Knowledge, Skills, Abilities: + Strong working knowledge of Tech Transfer, Computer System Validation , and Commissioning and Qualification processes + ... understand, interpret and apply internal policies and regulatory guidelines + Proficient computer skills, with knowledge of digital tools such as MS Office, and… more
- Medtronic (Tempe, AZ)
- …Define Receiving Inspection requirements as needed, including associated test method validation for internal Medtronic test methods. + Manage Supplier/Part setup and ... Green/BlackBelt, or Project Management Professional (PMP). + Experience andworkingknowledge of FDA regulations and ISO standards for Medical Devices. + Supplier… more
- Colgate-Palmolive (Orangeburg, SC)
- …Leads major and minor maintenance of automated and non-automated equipment through computer terminals, control panels and/or by manual means in the manufacturing of ... performs changeovers of automated equipment (making, finishing, injection molding) through computer terminals, control panels and/or by manual means in the… more