- Merck (Durham, NC)
- …and facility deviations + Author Change Control documentation for complex process , validation , analytical, equipment, facility/utility and/or automation changes. ... and collaboration skills responsible for implementation of technology transfer process knowledge, license approval support, commercial process enhancement… more
- Novo Nordisk (Durham, NC)
- …improvement methodologies preferred + Expert competence in one or more core validation areas (packaging, API, cleaning, utilities, process , or computer ... will also be responsible for the production activities & validation . Ensuring relevant compliance issues are addressed & handled...controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality… more
- Lilly (Concord, NC)
- …facility or area start up experience. + Previous equipment qualification and process validation experience. + Previous experience with Manufacturing Execution ... engineering group (both process and automation) supporting asset delivery, process development, commissioning, qualification, validation , and startup of the… more
- Lilly (Durham, NC)
- …+ Deliver equipment, lines, and supporting systems through technology transfer, process validation , and control strategy development. + Provide leadership ... facility or area start up experience + Previous equipment qualification and process validation experience + Previous experience with highly automated parenteral… more
- Lilly (Durham, NC)
- …formulation and/or filling in aseptic environment. + Previous equipment qualification and process validation experience. + Previous facility or area start up ... and leadership of the visual inspection and robotics engineering group ( process engineering, automation engineering, and technicians supporting visual inspection and… more
- Lilly (Durham, NC)
- …Previous facility or area start up experience + Previous equipment qualification and process validation experience + Previous experience with SAP or other ... of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation /qualification… more
- Fujifilm (Holly Springs, NC)
- …Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... criteria. * Relevant experience in analytical method development and validation . * Demonstrated application and knowledge of ICH guidelines...who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any… more
- Lilly (Concord, NC)
- …on the delivery of parenteral operations, specifically regarding technical transfer and process validation . TSMS PAR Scientist will support the formulation, ... ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Skills/Qualifications: Other Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing ... Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation . + Prepares periodic… more
- Honeywell (Charlotte, NC)
- …Specifications, Data Mapping, Approval of Functional specification / Data mapping, Validation process , Actual Validation completion, Progress Approvals ... data cleansing and support documentation. + Help define data validation requirements and document the process for...define data validation requirements and document the process for validation using various data extraction… more
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