Process Engineer

Location: Caguas, Puerto Rico
Date Posted: 01-16-2018
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. Test Methods for manufacturing area. In addition be able to review/perform process & equipment validations (IQ, OQ, PQ).

‚ÄčDuties and Resposibilities:
     
  •    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
  •    Performs other related tasks as may be assigned by supervisor
  •    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. 
  
Education:
The Process Engineer requires Bachelor Degree in  Engineering
 
Additional requirements:
The Process Engineer Must have knowledge in: Manufacturing Process Desing, Process Validations, Equipment Validations,  Manufacturing Equipment Qualifications, Test Method Validations, Procedures generation,  Component Qualification, QE, experience with documentation, reviewing and approving IQ, OQ, PQ., Project Management, Solid Dosage and Technical Writing Skills and parenteral experience.


Ultimate Solutions Corp is an Equal Opportunity Employer
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