- J&J Family of Companies (Wilson, NC)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... Coordinates and executes training of required personnel on the computer and automation systems validation ...working with FDA regulations + Experience in Computer system Validation working with… more
- Kelly Services (Wilson, NC)
- …field. + 5+ years of experience with GMP computer systems and software validation . + Strong working knowledge of FDA 21 CFR Part 11, GAMP 5, and CSV ... + Act as the subject matter expert for Computerized System Validation (CSV); support audits, inspections, and...Deliver training and create SOPs for end-users of validated systems . **Minimum Requirements:** + Bachelor's degree in Computer… more
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... from the planning stage to completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex… more
- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... other validation technical disciplines, such as equipment validation , computer system validation...plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This… more
- Curia (Rensselaer, NY)
- …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... responsibility is to provide quality review and approval of validation activities associated with changes to existing systems...special projects as directed by management + Perform the computer system periodic reviews in coordination with… more
- Unither Pharmaceuticals (Rochester, NY)
- …the Validation Document Library, maintains test equipment and documentation system . ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Assists in the execution of ... products and surface swabbing for testing as outlined by validation /qualification protocols. Maintains protocols and system documentation in… 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...the review of changes made under the Change Control System from a validation perspective + Provide… more
- Curia (Albuquerque, NM)
- …on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance Supervisory Responsibilities: This role does not have supervisory ... Analyst II is responsible for executing and supporting validation activities for equipment, processes, utilities, systems ,...supervision: + Small projects: 1-2 test scripts, a single system or piece of equipment, one end customer, duration… more
- Envista Holdings Corporation (Madison, WI)
- …execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems , including software. + Prepare comprehensive validation reports and analyze ... GMP regulatory requirements highly desired + Knowledge of software validation practices for IT and automated systems ...analysis and data interpretation. + Ability to quickly learn computer business systems and software required (ie… more
- ThermoFisher Scientific (Fair Lawn, NJ)
- …device industry. + Certification in validation or related field. + Familiarity with computer system validation (CSV). Our Mission is to enable our ... and compliance of our solutions. **What will you do:** + Develop and implement validation protocols and test plans for systems , processes, and products. +… more