WFI Verification Engineer Specialist

7 days ago

Fulton, New York, United States Lloyd Staffing Full time

We are seeking a highly skilled WFI Verification Engineer to support our projects in Rocky Mount, NC. As a key member of our project team, you will be responsible for performing verification activities related to water pretreatment systems, high-quality steam systems generation and distribution, and water for injection systems start-up, commissioning, and qualification.

Our ideal candidate will have at least 10 years of experience in qualification activities for Pharmaceutical Industries and a strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems. They will also possess hands-on experience in the development of Life Cycle documents such as Project Validation Plans, User Requirement Specifications, and Risk Assessments.

A bachelor's degree in engineering, science, or a related field is required, and fluency in English (reading, speaking, and writing) is essential. The selected candidate will work closely with our project team to ensure that all tasks are completed in strict compliance with best practices and regulatory requirements.

The salary for this position is estimated to be around $120,000 - $150,000 per year, depending on qualifications and experience. If you are a motivated and detail-oriented professional looking for a challenging opportunity, please submit your application.

Responsibilities:

  • Perform verification activities related to water pretreatment systems, high-quality steam systems generation and distribution, and water for injection systems start-up, commissioning, and qualification.
  • Support project activities within a cross-functional project team.
  • Define project strategy according to current standard operational procedures.
  • 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.

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.
  • 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).

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