Management Consulting Group · 2 months ago
ISIJP00011288 Validation Engineer 1 not avail for w2 ref
United States
Full-time
Remote
Senior Level, Lead/Staff
$74/hr - $74/hr
8+ years expManagement Consulting Group is seeking a Validation Engineer 1 for a remote position. The primary role involves supporting computer system validation activities while ensuring compliance with GxP regulations and documentation requirements.
Human ResourcesRecruitingStaffing Agency
Responsibilities
Responsible for oversight of all GxP-regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV), and Lifecycle procedures with Data Integrity requirements
Provide oversight of validation activities, lead the development and approval of validation documentation and risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessment of proposed changes to computerized systems
Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820, 21 CFR Part 11, Annex 11, and Data Integrity
Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Intuitive Surgical policies and procedures
Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Reports
Establish validation standards, develop testing protocols, document test results and maintain records for later analysis
Documentation and remediation of deviations resulting from validations/qualifications
Provide assistance and guidance in training co-workers on validation protocols and operating procedures
Author/Update assigned Operating Procedures (SOPs & DOPs), Policies, validation templates to ensure compliance with Company policies and federal regulations
Support regulatory agency inspections/audits, as required
Must be familiar with cGMPs and current industry guidelines
Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules
Maintains awareness of regulatory requirements
Understanding of FDA’s new guidance of CSA risk based approach validation
Qualification
Required
Good understanding of CSV, CSA, FDA regulations (21 CFR Part 11 & 820), GAMP5 & GxP regulations
Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards
Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs
Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools
Understanding of FDA's recent guidance on transition of CSV to CSA
Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills
Ability to work on complex projects with general direction and minimal guidance
Ability to handle multiple projects and meet deadlines
Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Bachelor's degree (B.S.) in related field or equivalent
8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system
Preferred
Hands-on experience with Microsoft word, Excel, PowerPoint & Visio
Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools
Company
Management Consulting Group
Management Consulting Group is a staffing company that offers recruiting and managed services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Todd Ghanizadeh
Chief Executive Officer
Company data provided by crunchbase