CSV Validation Associate

Company: Beacon Hill Staffing Group
Location: Saint Paul
Posted on: April 18, 2024

Job Description:

Position Summary: The Validation Associate will support the IT environment with oversight responsibilities. Key Responsibilities:

Author and review of validation packages and gap assessment of such for deliverables received from vendors providing testing and validation of internal SaaS systems
Management of the validation life cycle
Review and management of the various validation projects supporting the GxP systems
Documentation, execution and review of testing required to meet the intended use of the system
Maintenance of the validation documents in a controlled environment and review at all times against inspection readiness compliant with 21 CFR Part 11, Annex 11 and other guidance and regulations supporting CSV
Management and execution of system periodic reviews
Coordinate with various functions, business owners and IT to maintain validated state of systems
Identify, plan and outline responsibilities for validation efforts across GxP systems
Provide risk and impact assessments as required for change control and system updates

Requirements:

Bachelor's degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline.
Experience, Expert Knowledge &/or Competencies:
7+ years related experience in Computer System Validation.
Knowledge of regulatory requirements and experience working in a GxP and CSV requirements
Hands on experience in authoring validation documents and associated procedures (SOPs)
Strong interpersonal verbal and documentation skills

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/ Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you! Beacon Hill. Employing the Future---

Keywords: Beacon Hill Staffing Group, Woodbury , CSV Validation Associate, Other , Saint Paul, Minnesota