Validation Engineer

  • Humacao
  • Integrated Technology Eamp; Compliance Services
VALIDATION ENGINEER Seeking a Senior Validation Engineer that have experience in validation in new products, process and equipment validation .Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry. Responsibilities Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement validation standards on a daily basis. Presents interpretation of results for validation engineering projects of significant scope and complexity. Implements validation engineering policies and procedures in accordance with regulatory requirements and company manufacturing standards that affect multiple organizational units. Apply knowledge of validation engineering outside of area of expertise to broad many of assignments in related fields. Provides the technical validation engineering support of process and equipment issues in the laboratory or manufacturing environment. Work with qualification activities, utilities, facilities developing requirements and recommendation for process. Communicate with the staff and management on ways of implementing plans and recommendations. Skills and Qualifications EXPERIENCE IN NEW PRODUCTS INTRODUCTION EXPERIENCE IN MANUFACTURING PROCESS EXPERIENCE IN EQUIPMENT VALIDATION Basic Project Management Problem solving skills Negotiation, persuasion, facilitation and project cost development skills. Manage multiple tasks Able to work independently Strong oral and written communication skills. Fully bilingual Facilitates and organizes Requirements Bachelor's Degree in Engineering and 2+ years of Scientific experience. Integrated Technology and Compliance Services is an Equal Opportunity Employer