- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated ** Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory ... Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
- J&J Family of Companies (Raritan, NJ)
- …We are searching for the best talent for a Sr . Engineer, Computer System Validation (CSV) and Data Integrity (DI) to join ... Integrity, as well as GMP records and events quality systems . The Senior Engineer ensures compliance with...flawless execution of Computer System Validation and Data Integrity deliverables for GMP Systems… more
- Curia (Rensselaer, NY)
- …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... Senior Quality Assurance Validation Specialist in...special projects as directed by management + Perform the computer system periodic reviews in coordination with… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- US Tech Solutions (St. Joseph, MO)
- …GMP Lab systems and Equipment + Responsible for assuring a system /application meets its requirements as outlined in system specification (URS/FRS) per ... functional teams + Have solid experience working with validated systems . + Work with business representatives to ensure the...+ Technical writing Experience + Highly skilled in Computerized System testing and validation in the healthcare… more
- Charles River Laboratories (Rockville, MD)
- …have in-depth knowledge of accepted industry practices and regulatory requirements that govern computer system validation in the pharmaceutical industry. 21 ... during validation efforts regarding equipment, processes, test methods, facilities, computer software/ systems , SOPs, and other related issues to ensure… more
- Novo Nordisk (Bloomington, IN)
- …Validation Department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System Validation (CSV). The equipment/facility team ... performed routine TOC testing. The CSV group qualifies new computer systems and changes to computer...with clients and internal customers across the site. Relationships Senior Manager, Validation Essential Functions + Equipment… more
- Regeneron Pharmaceuticals (Troy, NY)
- … Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal ... a Principal QA Validation Specialist to support validation and qualification of computer systems...following: + Generates, executes and/or reviews master and completed computer system (s) qualification and validation … more
- Actalent (St. Paul, MN)
- …robust Cleaning Validation program. + Develop, execute, and maintain a robust Computer System Validation program. General: + Develop, update, maintain ... Demonstrated expertise in the development, execution, and maintenance of validation systems . + Strong knowledge of cGMP,...Process Validation requirements. + Working knowledge of Computer System Validation Requirements. +… more
- Kelly Services (Minneapolis, MN)
- …Utility, Equipment, and Process Performance Qualifications, as well as Cleaning and Computer System Validation programs. + **Collaboration & Support** ... Expertise** : Proven track record in developing and executing robust validation systems across multiple domains, including equipment, processes, cleaning, and… more