Validation Engineer

5 days ago

Rocky Mount, United States Intellectt Inc Full time

Role: Validation Engineer

Location: Rocky Mount, NC


Responsibilities:

  • Support project activities within a cross functional project team.
  • Define project strategy according to current standard operational procedures.
  • Perform verification activities to support water pretreatment systems, high quality steam
  • systems generation and distribution and water for injection systems start-up, commissioning
  • and qualification.
  • This includes change control initiation, project planning, documentation development and
  • approval.
  • Participate in technical meetings with client and design/construction companies.
  • Control project progress and resource planning.
  • Follow standard operating procedures and standards in a highly regulated environment.
  • Support project team in protocol generation, revision, execution and approval.
  • Develop new standard operating procedures associated with the scope of work.
  • Contribute substantially to the interpretation of results and the design of subsequent project
  • phases.
  • Request, evaluate and share technical information with project team.
  • Perform all tasks in strict compliance with best practices and regulatory requirements.
  • Provide feedback to client leadership regarding potential issues and concerns with
  • documentation elaboration and tasks execution.
  • Adhere to safe work practices.


About you

  • Bachelor’s degree in engineering, science or related field.
  • At least 6 years of experience in qualification activities for Pharmaceutical Industries.
  • Experience in commissioning and qualification activities related to water pre-treatment systems, high quality steam systems generation/distribution and water for injection systems
  • Ability to interpret engineering drawings and discuss technical solutions associated with WFI systems.
  • Hands on experience in the development of Life Cycle documents such as Project Validation
  • Plans, User Requirement Specifications and Risk Assessments.
  • Hands on experience in the elaboration and execution of FAT, Commissioning, SAT,
  • Installation Qualification, Operational Qualification and Performance Qualification Protocols and Qualification Reports.
  • Hands on experience in evaluation of welding activities, procedures and welding documentation.
  • Hands on experience in the elaboration of Standard Operating Procedures for operation and maintenance of WFI systems.
  • Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems.
  • Knowledge in WFI guidelines from International Society of Pharmaceutical Engineering.
  • Ability to manage resource planning, priorities, deliverables, and project schedule milestones.
  • Strong interpersonal, verbal communication, and technical writing skills.
  • Fluency in English (reading, speaking and writing) is a must.

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