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WFI Verification Engineer

4 months ago

Rocky Mount, United States Pharma quality europe srl Full time

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking 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 client 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.

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.

About you

Bachelor's degree in engineering, science or related field.

At least 8 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.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.