- Merck (Durham, NC)
- …the EMEA / AP or US region. **Primary Responsibilities:** + Delivery of best-in-class computer systems validation to capital projects. + Drive the adoption ... and coordinate activities across sites. + Ensure compliance with Computer Systems Validation (CSV) and...and Data Integrity to ensure manufacture and supply of quality pharmaceuticals. + Liaise with product teams/technology functions and… more
- Actalent (Winston Salem, NC)
- …as assigned by management. Essential Skills + Engineering, quality assurance, quality system , validation , systems engineering. + Understanding ... and best practices related to data integrity and computerized system validation . + Foster effective working relationships...practices. + Ensure continued GxP compliance of QC laboratory computer systems and software. + Perform additional… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Assists in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . + Assures compliance with SOPs ... our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and… more
- Astellas Pharma (Sanford, NC)
- … will be primarily responsible for the implementation, execution and assessment of quality systems , procedures, and records to support compliant GMP operations. ... This position works closely with Validation , Engineering, Manufacturing, Quality Control, Facilities, and Automation. **Responsibilities** + Provide hands on QA… more
- Ford Motor Company (Raleigh, NC)
- …experienced Software Developer in Test to join our team, specializing in embedded systems with a focus on automotive applications. As a Software Developer in Test, ... for our embedded software products. Your expertise in embedded systems and automotive industry knowledge will help ensure the... and automotive industry knowledge will help ensure the quality and reliability of our software solutions. What you'll… more
- Generac Power Systems (Durham, NC)
- …Construction Manager with a strong technical background in mechanical systems , specifically focused on chillers and liquid-to-the-chip cooling technologies. This ... expertise in overseeing and reviewing complex mechanical installations to ensure quality and compliance with project specifications. The ideal candidate will be… more
- Lilly (Concord, NC)
- …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, GAMP 5, 21 ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
- Bosch (Lincolnton, NC)
- …Ensures accurate data collection from production equipment and alignment of system configurations with operational and quality requirements. Coordinates ... MES-related activities such as parameter setup, user access control, interface validation with automation and ERP systems , and master data consistency.… more
- Lilly (Durham, NC)
- …with C&Q / Verification and Validation oversight including automation and computer systems validation . + Previous experience with capital project ... and Global quality groups including the Global Quality Systems , Engineering Technical Center, Global Parenteral...+ Previous use of KNEAT - or other electronic validation software. + Previous computer system… more
- GE Vernova (Wilmington, NC)
- …and cost-out + Champion nuclear safety culture; Ensure compliance with GEH policies, quality management system , and corrective action program + Deliver work with ... **Job Description Summary** Lead and mentor team responsible for Electrical systems associated plant cross- disciplinary and cross- systems simulation. Focus on… more