- Parexel (Indianapolis, IN)
- …and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications -** ... or other specialized computerized systems ** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of… more
- Reckitt (Zeeland, MI)
- …and inspection systems + Work experience in a regulated industry requiring computer system validation + Experience leading automation projects through ... identification of system user requirements, design of systems , and commissioning and validation of ...current standards of control system platforms and computer system validation + Demonstrated… more
- Bristol Myers Squibb (Summit, NJ)
- …Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. ... new equipment, facilities and utilities, as well as maintaining equipment systems in a qualified/validated state according to established policies and procedures.… more
- Lilly (Indianapolis, IN)
- …for both technical and non-technical audiences + Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** + Minimum BS ... in major pharmaceutical companies and in Manufacturing Operations with extensive System integration of applications, systems and platforms **Additional… more
- J&J Family of Companies (Raritan, NJ)
- …health authority inspectors from regulatory agencies on matters related to IT processes, computer system validation , and other technical topics and ... 211 and Part 820, and how these apply to Computer Systems . + Expert knowledge of IT...directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Computer System Validation (CSV), Inspection… more
- J&J Family of Companies (Anasco, PR)
- …, Automation and familiar with Vision Systems , preferred. + Experience in Computer Systems Validation , preferred. + Proven experience with validation ... monitoring and support to manufacturing lines + Provide training on process and validation requirements to operators and engineers + Writes, develops, and execute … more
- Robert Half Technology (Bridgewater, NJ)
- …+ Participate in commissioning and qualification of IT systems and assist in Computer System Validation (CVS) activities, such as draft URS, IQ/OQ/PQ ... Caliber, and other industrial systems . - Advanced + Experience with Computer System Validation (CVS) and Change Control processes - Advanced +… more
- Catalent Pharma Solutions (Kansas City, MO)
- …PM interests. Performs Maintenance Approver role on department TrackWise records and Computer System Validation (CSV) reviews Support deviation investigation ... team members), helping to maintain the computerized maintenance management system (CMMS), managing the service request/work order process, coordinating calibration… more
- BeOne Medicines (Pennington, NJ)
- …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). (6+ years) + Strong experience ... eBR, eLogs, etc.. + Technical Transfer experience including equipment qualification, process validation , and computer system validations. + Hands-on… more
- Lilly (Concord, NC)
- …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control ... understanding of the process and its associated equipment, facilities, computer systems and operations + Lead and...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… more