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Sr. Validation Engineer

Arroyo, PR
We are seeking a Sr. Validation Engineer that will provide support to Equipment and process Validation. Must be able to perform Equipment Validations and Qualifications. In addition, be able to review/perform equipment validations (IQ, OQ, PQ). 

Duties and Responsibilities:

 Plan, write, coordinate, execute, summarize, review process validation 
• Validation, risk assessments, FAT, SAT, Commissioning, IQ, OQ, PQ,  
• Deviations, results and approvals for Equipment and Tooling 
• Product Transfer, IQ, OQ, PQ, and deviations.
• Provide support and approval for all documentation required for project 
• Process & Equipment Validation and qualification
• Set-up of Incoming Inspection equipment, ensure satisfactory operation  
   and inspections
• Generate new SOP'S 
• Assist meetings and provide weekly reports when applicable
• Project planning and executing, as well as generate CRs for new 
• Performs other related tasks as may be assigned by supervisor
• Assist in coordination of production steps for new product introduction to manufacturing 
Requires minimum 4 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry working with Equipment Validation/Qualifications.
Bachelor’s degree in engineering (Mechanical or Industrial)
Additional requirements:
Must have knowledge in: Equipment Validations, Equipment Qualifications, experience with documentation, reviewing and approving IQ, OQ, PQ. 

Ultimate Solutions Corp is an Equal Opportunity Employer
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