DESCRIPTION
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.

EDUCATION
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. 
 
 
​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   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. 

REQUIREMENTS/SKILLS

• 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