- Senior Validation Specialist Añasco
- Intellectt Inc in Añasco, , Puerto Rico
- jobs
- 2 months ago
jobs description
Responsibilities
• * Plan, develop, and implement documentation, procedures, and training for the engineering team.
• Participate in the Validation Life Cycle of regulated projects by reviewing validation documentation and participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing, and deviation management.
• Generate validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports.
• Provide statistical analysis of the data to support the reports.
Key Qualifications
• * Knowledge of FDA, OSHA, EPA, and GMP and ISO requirements.
• Knowledge in Organizational Excellence and Lean/Six Sigma.
• Strong Project Management skills.
• Ability to lead teams through complex projects and provide departmental technical leadership.
Requirements
• * 7+ years of experience in a related field.
• Strong understanding of verification and validation processes, including early software or computer systems defect detection and removal, inspection, and testing methods.
• Ability to analyze test strategies, develop test plans, and execution documents, and review customer deliverables.
• Strong knowledge and understanding of Computer Systems Validation Life Cycle and regulatory requirements.
Intellectt Inc.
Intellectt Inc. is looking for a highly skilled Validation Engineer III Senior to join our team.
Añasco Puerto Rico