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Job

Validation Engineer

  • Job ref:

    10366

  • Location:

    Wilmington, United States

  • Sector:

    Quality Engineers

  • Job type:

    Contract

  • Contact:

    Bob Giusti

  • Published:

    4 months ago

  • Consultant:

    Bob Giusti

Validation Engineer

 

Responsibilities:

  • Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Develops validation master plans, validation protocols, process flow diagrams, test cases, or standard operating procedures.
  • Identifies deviations from established equipment, product or process standards and provide recommendations for resolving deviations.
  • Conducts validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
  • Coordinates the implementation or scheduling of validation testing with affected departments and personnel.
  • Adheres to all customer/company and GMP procedures, along with safety regulations within the workplace.

Desired Skills & Experience

  • Bachelor's degree in a technical field i.e., Biology, Chemistry, Engineering and minimum 2 to 10 years related experience and/or training; or equivalent combination of education and experience.
  • Experience Writing and Executing Protocols
  • Strong understanding of Equipment and Processes including Tanks, Columns, USP Water Systems, and HVAC Equipment.
  • Experience writing User Requirements, Functional Requirements, Design Specifications, FAT’s, SAT’s, IQ’s, OQ’s, PQ’s.
  • Experience executing FAT’s, SAT’s, receipt verification, IQ, OQ, PQ.
  • Knowledge of cGMP Cleaning Validation requirements and techniques.
  • Knowledge of cGMP Equipment, Process and Product Validation requirements and techniques