- Amgen (Holly Springs, NC)
- …engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise ... to support operations upon start up. + Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of… more
- US Tech Solutions (Durham, NC)
- …teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within ... Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report… more
- Cognizant (Raleigh, NC)
- …in managing the implementation and maintenance of Emerson's DeltaV automation system within our life science manufacturing and research environments. **Cognizant ... DeltaV:** Proven experience in designing, implementing, and maintaining DeltaV systems . **Industry Knowledge:** Experience in the life science industry… more
- Amgen (Holly Springs, NC)
- …providing daily Engineering support at the Amgen North Carolina site. + Provide system ownership for process systems and equipment supporting operations at the ... construction, startup, commissioning and qualification of new or modified systems . + Identify, support, and/or lead implementation of engineering-based improvements… more
- Caterpillar, Inc. (Clayton, NC)
- …you will have the opportunity to contribute to the detailed design, development, and validation of the STTT's designed in Clayton, NC and built in Athens, GA. This ... play a key role in concept, design, development, and validation of the STTT. **What You Will Do:** +...+ Releasing drawing packages using Teamcenter and Engineering Data System (EDS) **Additional Info** : + **Office Model:** Caterpillar… more
- ManpowerGroup (Raleigh, NC)
- … within a regulated environment. + Greenfield project experience. + Familiarity with electronic validation systems (eg, KNEAT Gx). **What's in it for me?** + ... + Perform Risk-Based Analysis and validate various Part 11 Systems . + Select validation objectives and standards, prepare protocols, and draft validation… more
- Fujifilm (Holly Springs, NC)
- …and monitoring * Ensures integration of TT process with other Quality Systems (Deviation/CAPA, Change Control, Validation ) * Provides guidance and quality ... equipment, hygienic utilities, quality systems , automation, manufacturing & IT Systems , and/or validation methodologies * Understanding of Data Integrity,… more
- Lilly (Concord, NC)
- …. Demonstrated ability to influence without authority . Solid knowledge of Computer System Validation process . Demonstrated ability to analyze, anticipate, and ... next generation MES team and third parties in the validation of the MES System during the...issue escalations . Produce and maintain local project and validation documentation . Ensure systems remain in… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …compliance (such as GxP and FDA), and life sciences processes. As a Business Systems Analyst, you will play a critical role in designing and optimizing solutions for ... This role involves strategic oversight and technical expertise in SAP systems , working closely with cross-functional teams to enhance material management,… more
- Novo Nordisk (Clayton, NC)
- …in cGMP's & validation required + Strong knowledge in Quality Management Systems required + Must be ability to perform tasks independently, accurately & within ... make what matters. The Position Responsible for the production activities & validation . Ensures relevant compliance issues are addressed & handled in close… more