WFI Verification Specialist

5 days ago


Rocky Mount, North Carolina, United States Lloyd Staffing Full time
Job Overview

Lloyd Staffing is seeking a highly skilled WFI Verification Engineer to support projects on a long-term contract basis. As a key member of our team, you will be responsible for ensuring the quality and compliance of water pretreatment systems, high-quality steam systems generation and distribution, and water for injection systems start-up, commissioning, and qualification.

Key Responsibilities
  • Support project activities within a cross-functional project team, defining project strategy according to current standard operational procedures.
  • Perform verification activities, including change control initiation, project planning, documentation development, and approval.
  • Participate in technical meetings with clients and design/construction companies, controlling project progress and resource planning.
  • Follow standard operating procedures and standards in a highly regulated environment, supporting project team in protocol generation, revision, execution, and approval.
  • Develop new standard operating procedures associated with the scope of work, contributing substantially to the interpretation of results and the design of subsequent project phases.
  • Request, evaluate, and share technical information with project team, performing 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, adhering to safe work practices.
Requirements
  • Bachelor's degree in engineering, science, or a related field.
  • At least 10 years of experience in qualification activities for Pharmaceutical Industries.
  • Experience in commissioning and qualification activities related to water pretreatment 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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