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Process Engineer

San Lorenzo, PR
The Process Engineer will lead and execute a project regarding packaging components changes for international markets, using their experience in process and packaging validation to generate and close the required changes. Must be able to perform Process & Equipment Validations and Qualifications.

Completer bachelor’s Degree in Engineering related field and minimum of 3-5 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry working with Process Validation/Qualification and Packaging Validations. 
  •    Plan, write, coordinate, execute, summarize, review process validation protocols.   
  •    Validation, risk assessments, FAT, SAT, Commissioning, IQ, OQ, PQ,  
  •    Deviations, results and approvals for Equipment and Tooling 
  •    Product Transfer, IQ, OQ, PQ, Deviations, results and obtain approvals for New Sealer.
  •    Provide support and approval for all documentation required for Component.  
  •    Qualifications and Test Methods for project components and End Items
  •    Provide support and approval for all documentation required for project deliverable.
  •    Process & Equipment Validation and qualification
  •    Set-up of Incoming Inspection equipment, ensure satisfactory operation and inspections.
  •    Generate new SOP'S   and Manufacturing Process Information - MPIs
  •    Assist meetings and provide weekly reports when applicable.
  •    Project planning and executing, as well as generate CRs for new document.
  •    Performs other related tasks as may be assigned by supervisor.
  •    Assist in coordination of production steps for new product introduction to manufacturing. 
  • Must have knowledge in: Validation Master Plan, Process Validations, Equipment Validations, Equipment Qualifications, Manufacturing Procedures generation, Component Qualification, QE, experience with documentation, reviewing and approving IQ, OQ, PQ. Technical Writing Skills.
  • Adaptiv
  • ARIBA, e-Market Place
  • JDE
  • MES
  • Compliance Wire
  • Teams
  • Planisware
  • T-Bird
  • Technical writing
  • Self-starter
  • Problem Solving
  • MS Office – Excel, Visio, Power Point, Microsoft Project, Word
  • Project Management experience managing multi-sites project is a plus.
  • Excellent verbal and written communication in English.
Ultimate Solutions Corp is an Equal Opportunity Employer


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