- Sunrise Systems Inc (Warren, NJ)
- …responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems , review of validation and qualification documents for ... with GMP, Quality and compliance. Previous experience as a computer system validation / quality assurance for...(eg Veeva). Drives use of best practices during IT systems design, validation , and use. Must be… more
- Amerantbank (Miramar, FL)
- …meetups.Collaborate with the Model Risk Management (MRM) Unit with the validation of the models, providing the required documentation, executing back-testing, ... compliance, access management, and control policies and that it meets the qualification and assurance requirements of the organization.Be a data steward to define… more
- Amerantbank (Miramar, FL)
- …meetups.Collaborate with the Model Risk Management (MRM) Unit with the validation of the models, providing the required documentation, executing back-testing, ... compliance, access management, and control policies and that it meets the qualification and assurance requirements of the organization.Be a data stewards to define… more
- Catalent Pharma Solutions (Chelsea, MA)
- …its kind for DPI in North America. Catalent Pharma Solutions is hiring a Computer System Validation (CSV)/ Qualification Engineer is responsible for ... managing, developing, and implementing the Computer System Validation program and equipment qualification for the site to ensure compliance with local and… more
- University of Washington (Seattle, WA)
- …Department of Laboratory Medicine and Pathology has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + 40 ... + Lead and oversee the validation and qualification processes for GxP computerized systems and...manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status,… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the… more
- PCI Pharma Services (Rockford, IL)
- …reviews. 4. Computer Validation Specialization a. Write/Execute/Summarize qualification protocols for all computer systems software, hardware, ... differential, air quality, and fundamentals of heating, air conditioning, and refrigeration systems . - Computer Validation Specialization: Ability to perform… more
- Bristol Myers Squibb (Devens, MA)
- …required. + A minimum of 7+ years relevant experience with process equipment, computer systems , manufacturing process control systems (automation) and ... and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers… more
- Bristol Myers Squibb (Bothell, WA)
- …+ Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data ... cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex...as necessary. + Oversee the qualification and validation of laboratory instruments, equipment, and systems ,… more
- System One (Summit, NJ)
- …expectations are being met. + Provides technical support and guidance on equipment and computer systems qualification and validations issues. + Maintains a ... process. + Supports the execution of equipment qualifications and validation protocols. + Supervises vendors for qualification ...cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities + Participate on interdepartmental project ... of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is… more
- Colgate-Palmolive (Hodges, SC)
- …(C&S) processes, water & critical utility systems , computer control systems , etc. Ensures site Validation Program appropriately connects to other plant ... in validation activities, eg drafting/executing/completing equipment or instrument qualification , formula validations, computer system validation , etc.**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as ... Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global...More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification … more
- PCI Pharma Services (Philadelphia, PA)
- …- Sterilization, Sterility Assurance, and Utilities/Facilities is responsible for qualification , validation , and lifecycle management of terminal sterilization ... qualification and temperature mapping. Develops and maintains associated Validation Master Plans, Standard Operating Procedures, Work Instructions, as well as… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment re- qualification… more
- System One (Summit, NJ)
- … validation activities. + Configures and documents the configuration of computerized systems + Develops validation / qualification deliverables such as ... change management process. + Supports the execution of equipment qualifications and validation protocols + Supervises vendors for qualification functions. +… more
- PCI Pharma Services (Rockford, IL)
- …for planning and coordinating daily validation efforts for the qualification of pharmaceutical packaging, computer systems /applications, and, facility ... departments. + Oversees and manages the team to conduct qualification and validation activities. + Oversees team...procedures, work instructions, and job aids. + Experience with computer systems , HVAC systems , and… more
- ThermoFisher Scientific (Allentown, PA)
- …Engineer III, you will be responsible to interact with several departments to provide validation support for computer systems , equipment and processes, along ... Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and the resulting Process Performance Qualification … more
- Curia (Albuquerque, NM)
- …work orders, and validation master plans for cleaning, facilities, packaging systems , and computer -related systems at Curia. Essential Duties and ... initial qualifications and requalification of facility, equipment, process, cleaning and computer systems + Responsible for directing and providing quality… more
- Curia (Albuquerque, NM)
- …of work for release of equipment tested. + Assist in the review of validation protocols for computer related systems , environmental monitoring, process ... and facilities department to ensure proper installation and operation of systems both before and after validation . Additional responsibilities include… more
