- J&J Family of Companies (Jacksonville, FL)
- …high quality. + Assists in tasks associated with process validation (Installation Qualification, Operation Qualification, Performance Qualification, Computer ... **Requirements** : + Bachelor's degree or equivalent in Engineering, Science or Computing/ Computer Systems or related degree is required. A recent graduate is… more
- PACIV (San Juan, PR)
- …+ Performance Qualification + Detailed understanding and experience with current regulations for Computer System Validation , such as FDA cGMPs for the 21st ... and hands-on experience of equipment/system commissioning, qualification (C&Q), and/or validation (CSV) in regulated industries. + Currently working in device… more
- Curia (Albuquerque, NM)
- …engineers and technicians, fostering skill development and knowledge sharing. + Support Validation and Computer Systems Validation activities to ensure ... objectives. + Lead complex projects with minimal oversight, balancing quality, validation , production, and regulatory considerations in all decision-making. + Mentor… more
- Lilly (Branchburg, NJ)
- …or Werum PAS-X). + Minimum 3+ years experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance. + ... * Review and approve documentation related to areas of responsibility ( Validation Lifecycle documents, SOPs, policies, executed IQPQ protocols, etc.) as appropriate.… more
- PACIV (Indianapolis, IN)
- …knowledge of Data Historian systems, particularly OSI PI. + Understanding of Computer System Validation lifecycle and FDA regulatory requirements. + ... systems to enhance reliability, compliance, and performance. + Collaborate with the Validation Team to ensure automation systems align with regulatory and quality… more
- Lilly (Lebanon, IN)
- …both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS in ... matter expertise on data historian systems design, development, installation, testing, validation , and lifecycle support. * Ensure solutions are delivered by system… more
- Quality Consulting Group (Juncos, PR)
- …Change control of Medical Devices + Equipment Commissioning / Qualification + Process Validation 4. Computer System Validation (CSV) + Manufacturing, ... degree in engineering + 4 years of relevant experience + Proficient in validation process, CSV, PV + Proficient in Troubleshooting, Equipment Setups + Proficient in… more
- Curia (Albany, NY)
- …the operational excellence; * Establish and maintain an efficient and compliant validation program including computer software validation and instrument ... programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, and analytical reports; * Along with the quality associates, be… more
- PCI Pharma Services (Bedford, NH)
- …experience troubleshooting complex analytical or microbiology equipment + Familiarity with computer systems validation and equipment software + Excellent ... + Own the full lifecycle of QC testing instrumentation: induction, qualification, validation , decommissioning, and beyond + Serve as the main point of contact… more
- Lilly (Pleasant Prairie, WI)
- …measuring value against globally and locally defined targets. + Maintain robust computer system validation and data integrity capabilities, following globally ... implementing and maintaining compliance to CFR 21 Part 11 computer system validation regulations. + Experience with...to CFR 21 Part 11 computer system validation regulations. + Experience with audits, compliance assessments, findings… more