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WFI Verification Specialist
2 months ago
Join INTELLECTT INC as a WFI Verification Engineer and take on a challenging role in the pharmaceutical industry.
About the RoleWe are seeking a highly skilled and experienced WFI Verification Engineer to support our project activities within a cross-functional project team. As a WFI Verification Engineer, you will be responsible for defining project strategy according to current standard operational procedures and performing verification activities to support 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.
- 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.
- 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.
- 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.
