SR. VALIDATION ENGINEER
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
• 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)
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