Responsibilities and Skills of Validation Engineer

Validation Engineer – Skills and Responsibilities

The Validation Engineer is responsible for the qualification and Validation of equipment and the systems and also for assisting in the selection, design and competitive price negotiation for equipments. Work as an info resource to the validation technicians, vendors, contractors etc.

Skills Required

  • A bachelor’s degree in science or biological or pharmaceutical manufacturing.
  • Should have up to date knowledge on the validation requirements, practices and procedures.
  • Must possess good technical writing ability.
  • Should have knowledge to study, isometric, P&ID and as built drawings.

Responsibilities

  • Must write validation protocols and reports.
  • Should perform activities relating to validation such as thermal studies, cleaning, equipment and utility validation.
  • In order to execute protocol, they should often interact with the manufacturing sciences and other engineering departments.
  • Write master plans relating to any specified projects and conduct meetings to execute the validation plan.
  • Design and write summaries for regulatory compliances.

Job responsibilities often vary as the validation engineer may be responsible for process validation of biological proceeds, method validation, sterility validation, Cleaning and shipping validations etc.

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