Validation Engineer – Añasco

Senior Engineer with experience in the FDA regulated industry. Proven experience in computer system validation (CSV), data integrity, qualification of automated manufacturing, testing, vision inspection systems, and packaging equipment. Experienced in an automated PC/HMI/PLC based case packaging manufacturing system, and related packaging/serialization equipment on highly automated syringes packaging line. Developed validation documentation for a fully automated steam sterilization trace and track system. Temporary contract 1379
Requisitos:
Bachelors Degree in Engineering with at least 3 years of experience in regulated manufacturing environments. Knowledge in Organizational Excellence and Lean/Six Sigma is preferred. Strong Project Management skills is preferred. Knowledge of cost control, and development of guidelines, trainings, and maintenance programs is preferred. Must have an understanding of verification and validation processes, including early software or computer systems defect detection and removal, inspection, and testing methods (e.g., types, levels, strategies, tools and documentation). Have an understanding of Computer Systems Validation Life Cycle and regulatory requirements (GAMP 5 and FDA guidelines, among others). Must have excellent communication skills and a strong track record of working cross-functionally.