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Process Engieer

Caguas, PR

Process Engineer
Description
 
The Process Engineer will provide support to Equipment and process Validation. Must have experienced with process design and be able to perform Process & Equipment Validations and Qualifications. Product Transfer for manufacturing area. In addition be able to review/perform process & equipment validations (IQ, OQ, PQ).The successful candidate must have experience in Quality Engineering areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.
 
Responsibilities:     
  •   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 
  •    Assist meetings and provide weekly reports when applicable
  •    Project planning and executing, as well as generate CRs for new document
  •    Assist in coordination of production steps for new product introduction to manufacturing 
Experience:
The Process Enineer requires minimum of 5+ years of experience in the pharmaceutical, Medical Device or other FDA regulated industry working with Process Design, Equipment Validation/Qualification and Process Validations. 
  
Requirements:
The Process Engineer requires Bachelor Degree in  Engineering
 

Integrated Technology and Compliance Services is an Equal Opportunity Employer
 

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