- Merck & Co. (Lower Gwynedd, PA)
- …(from onboarding and maintenance to retirement), and manage and improve the computer system validation of laboratory equipment. This individual should be ... processing and operational and informational technology systems.Apply deep expertise in the computer system validation process of lab equipment, including the… more
- Merck & Co. (Lower Gwynedd, PA)
- …achieve financial and operational objectives for the Regulated Robotics teamDrives the computer system validation efforts for all departmental automation systems ... vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. As the AdVAnce facility will not be fully… more
- Merck & Co. (Rahway, NJ)
- …quality deliverables.Effective analysis and report programming development and validation , utilizing global and therapeutic area (TA) standards and following ... programming activities for Early Oncology clinical development projects.Review the quality and reliability of clinical studies using deep scientific knowledge,… more
- Merck & Co. (North Wales, PA)
- …delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation , and other global regulatory requirements that ... Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system owners ... implementation teams (including external vendors) in the design, development, implementation, validation , roll-out, training and support of global and regional DS… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Aequor (Northborough, MA)
- …these functions, Packaging interacts with and receives support from the Quality Assurance, Materials Management, Facilities Engineering, Validation , Metrology ... high value product vials in various stages of packaging completion. Use computer -based systems for data collection, data analysis, timecards, e-mail and inventory… more
- Twist BioScience (South San Francisco, CA)
- …of production processes, project management, Supply Chain andWarehouse Management, Validation , and Quality Systems. Prior experience supporting other ... lead the master data governance processes for Twist Operations toensure a high quality of data throughout all systems where master data is used. Creates,reviews, and… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups. This position will be for second ... and maintenance of equipment/utility systems.Assist with execution of calibration, automation, validation and additional testing, as requiredWork within a team to… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Fujifilm (College Station, TX)
- …understanding of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- System One (Warren, NJ)
- …and experience with GMP, Quality and compliance. + Previous experience as a computer system validation / quality assurance for life sciences company ... + Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities;… more
- Lilly (Indianapolis, IN)
- …and mentorship in the execution of change controls, equipment qualification, process validation , computer system quality , deviations, and complaint ... customer service, and GMPs + Provide consultation and interpretation of quality guidance documents regarding qualification / validation , cleaning, change… more
- Lilly (Lebanon, IN)
- …- Computer Systems Quality Assurance is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. This ... relevant experience + 1+ years of experience in Automation/QC Labs/IT, Quality , or computer system validation in the pharmaceutical industry **Additional… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- Robert Half Technology (New Haven, CT)
- …Responsibilities * Develop validation plans, protocols, and summary reports for computer systems to ensure regulatory compliance and quality standards are ... Description We are offering an exciting opportunity for a Computer Systems Validation Specialist in New Haven...* Identify critical aspects of systems that impact product quality or patient safety through risk assessments and gap… more
- University of Washington (Seattle, WA)
- …of Laboratory Medicine and Pathology** has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + Temporary ... with 21CFR Part 11 compliance. + Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems. +… more
- Capgemini (Nashville, TN)
- …remains accurate, complete, and reliable over its lifecycle. 2.Create and manage the computer system validation strategy and approach, ensuring it aligns with ... identified issues or potential failures, and ensure they are integrated into the validation and quality processes. 9.Follow change control procedures for any… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Takeda Pharmaceuticals (Social Circle, GA)
- … validation activities. + Review and approve computer system related validation documents and quality system records such as deviations, CAPA, and change ... maintenance, account management, troubleshooting and training. Additionally, you will provide quality support relative to computer systems on site, including… more
