Lloyd Staffing | Water Engineer | rocky mount, nc

1 month ago

rocky mount, United States Lloyd Staffing Full time

WFI Verification Engineer


Long term Contract


Our client is a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries.


The constant growth has created an urgency on a long-term consultant project for a WFI Verification Engineer to support our projects in Rocky Mount, NC.


You will be responsible for

· 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 clients 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.


· Requirements:

· Bachelor's degree in engineering, science or 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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