CSV/Validation Analyst-2 Openings (Remote)

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.Please apply or call one of us to learn moreFor further inquiries regarding the following opportunity, please contact one of our Talent SpecialistsInfant at 224 5071261Sivanesan at 224 369 0756Title: CSV/Validation Analyst-2 Openings (Remote)Location: Remote within the United States but will be working on Pacific Time ZoneDuration: 1 Year with possible extensionsDescription 7 - 9 YEARS OF EXPERIENCE IN THE FOLLOWING: ResponsibilitiesLead/support validation efforts and deliverables for projects requiring validation. Create and execute validation test scripts and document test results in accordance with standards. Review and evaluate validation assessments for application systems/projects. Review/revise Validation Policy and SOPs as directed. File validation documentation within following Quality Assurance Library guidelines. CompetenciesOutstanding verbal and written communication skills, Customer Service Focused; Information Technology background, experience within a Quality/Regulated environment; System Audit /Validation background/experience; excellent organizational and project management skills including SDLC. QualificationsAssociate Degree minimum or equivalent combination of education and work experience. Minimum 2 years experience with validated systems within a regulated industry. Experience writing Standard Operating Procedures and validation policies. Advanced knowledge and understanding of IT concepts and word processing and spreadsheet skills. Laboratory, product, and manufacturing knowledge/experience are a plus.MANAGER LOOKING FOR BELOWResponsible for following ADC quality system procedures for non-product computer systems validation, primarily SaaS validation.Including project management, risk assessment, requirements definition, testing and all documentation.Identifying and working with / taking directions from system owners, subject matter experts, and quality approvers.-Must have significant experience in medical device computer systems validation, including SaaS, in compliance with FDA requirements. Must have experience with validation of 21 CFR Part 11 requirements.-No education requirements but must have high school diploma or GEDThis is not a Software/Systems tester position but a position where the candidate will be responsible for soup to nuts validation which will include project management, risk assessment, requirements definition, testing and all documentation. So will not be just IQ, OQ PQ etc.About UsDivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.