- Biomat USA, Inc. (Research Triangle Park, NC)
- …met. + Develops cGMP operating procedures that relate to process, information systems , and equipment validation /qualification. + Ensures compliance with SOPs ... for routine use. This includes donor center processes and information systems . + Analyze validation data to ensure acceptance criteria are met. + Write … more
- Novo Nordisk (Clayton, NC)
- … protocols preferred + Experience in managing projects preferred + Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus + ... what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation ...& oversee change control activities for QC equipment & systems + Follow all safety and environmental requirements in… more
- Stantec (Raleigh, NC)
- …stored in GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The ... commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify that they are designed, installed,… more
- Amgen (Holly Springs, NC)
- …solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity ... part of Amgen's plan to be a carbon-neutral company by 2027. **Senior Manufacturing Systems Engineer: Automation - BAS / PLC** **Live** **What you will do** Let's do… more
- Lilly (Durham, NC)
- …irregular hours, shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality ... ground up as a member of the site IT organization. The Manufacturing Execution Systems (MES) Systems Engineer is responsible for the deployment and continuous… more
- Merck (Durham, NC)
- …technical services support in the areas of equipment and automation systems , validation , deviation management and product franchise. Specific assignments ... Good Manufacturing Practices (GMP), Immunochemistry, Maintenance Engineering, Manufacturing Execution Systems (MES), Manufacturing Process Validation , Process Optimization,… more
- Lilly (Durham, NC)
- …C&Q / Verification and Validation oversight including automation and computer systems validation . + Previous experience with capital project delivery. + ... with Network and Global quality groups including the Global Quality Systems , Engineering Technical Center, Global Parenteral Program, Pharmaceutical Delivery … 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)
- …with C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control strategy to make ... of the process and its associated equipment, facilities, computer systems and operations + Lead and establish annual quality...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… more
- Lilly (Concord, NC)
- …C&Q / Verification and Validation oversight including automation and computer systems validation + Proficiency with computer systems including Microsoft ... formulation, filling, and visual inspection + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other electronic validation… more