Sr. Validation Scientist

Location: Caguas, PR
Date Posted: 09-08-2017
Sr. Validation Scientist

 
Description
 
Seeking a Senior Validation Consultant that have advanced validation in Commissioning, Qualification, Validation experience .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 EQUIPMENT COMMISSIONING, QUALIFICATION, VALIDATION
  • EXPERIENCE IN ASEPTIC PROCESSES
  • EXPERIENCE IN: SIX SIGMA, TROUBLESHOOTING, PROCESS VALIDATION, EQUIPMENT CHARACTERIZATION.
  • ADVANCE VALIDATION KNOWLEDGE ( EQUIPMENT QUALIFICATION, CLEANING STERILIZATION)
  • EXPERIENCE IN NON-CONFORMANCE INVESTIGATION
  • 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
Master's Degree in Life Sciences or Engineering and 3 years of Scientific experience or Bachelor's Degree in Life Sciences or Engineering and 5 years of Scientific experience.
 
Integrated Technology and Compliance Services is an Equal Opportunity Employer
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