CSV (WFI) Engineer

Company: PQE Group
Location: Rocky Mount
Posted on: August 3, 2022

Job Description:

PQE is a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With a network of more than 900 consultants, PQE delivers the highest level of expertise to Life Science customers worldwide and has successfully completed 12,000+ projects for 1,400+ clients. An international group, PQE operates in over forty countries throughout Europe, Asia, and the Americas. PQE offers worldwide coverage with offices and representatives across Europe, North America, Asia, the Middle East, and Latin America, in order to better serve these specific local markets. Further information can be found at www.pqegroup.com.Due to constant growth, PQE is looking for a new Computer System Validation Lead. This will initially be a 6 month contract assignment that will be worked on site in Rocky Mount, NC with a possibility of extension.Responsibilities

• Support project activities within a cross functional project team.
• Perform verification activities to support process control system start-up and verification. This includes documentation development and approval.
• Communicate progress and issues to management.
• Follow standard operating procedures and standards in a highly regulated environment.
• GMP verification protocol generation and execution.
• Develop new standard operating procedures.
• Perform all tasks in strict compliance with best practices and regulatory requirements.
• Provide feedback to leadership regarding potential issues and concerns with documentation.
• Adhere to safe work practices.Requirements
  • Bachelor's degree in science, engineering or related field.
  • At least 5 years of experience in validation of computerized systems related to clean utilities (such as water for injection systems, HVAC systems), process control system, SCADA systems and process equipment's and qualification of IT infrastructure.
  • Hands on experience in the development and/or execution of Risk Assessments, Analysis of 21 CFR Part 11 Applicability/Requirements, Traceability Matrix, Installation Qualification Protocol, Operational Qualification Protocol, Qualification Reports and Standard Operating Procedures.
  • Experienced in Rockwell Factory Talk, Microsoft SQL Server, Microsoft NET Framework and Allen Bradley PLC systems preferably related to verification of process control systems.
  • Previous work experience in verification of PLC, HMI, SCADA, batch, and historian is required.
  • Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems.
  • Ability to manage priorities, deliverables, and schedule milestones.
  • Requires strong interpersonal, verbal communication, and technical writing skills.

Keywords: PQE Group, Rocky Mount , CSV (WFI) Engineer, Engineering , Rocky Mount, North Carolina