Water Engineer
3 days ago
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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rocky mount, United States Lloyd Staffing Full timeWFI Verification EngineerLong term ContractOur 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...
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