Descripcion
HVAC System Replacement (Capital Project). Active participation in Validation Life Cycle of regulated projects with documentation, application and deviation management. Development and execution of validation protocols. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Troubleshooting computer and automation systems. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete Non-Conformance and CAPA investigations and prepare reports. Manage and supervise the installation of equipment and controls/software modifications for automated equipment. Assists with vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, set-up, training, start-up, and troubleshooting. Oversee validation contractor resources. Participate in external audits.
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Requisitos - Requirements
Bachelors Degree in Engineering with at least 7-10 years of related experience. Previous experience in HVAC replacement projects. Strong Project Management skills. Knowledge of cost control, development of guidelines, trainings, and maintenance programs. Ability to lead teams in complex projects and provide technical leadership. Must have a thorough understanding of verification and validation processes. Strong knowledge and understanding of Computer Systems Validation Life Cycle and regulatory requirements (GAMP 5 and FDA guidelines, among others). Must generate Validation Plans, User Requirement Specifications, Functional Requirement Specifications, System Design Specifications, traceability matrix and validation protocols (IQ/OQ/PQ). Must have excellent communication skills in Spanish and English, with strong track record of working cross functional. Temporary contract (one year) 1372
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