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Validation Engineer

Company: PQE Group
Location: Rocky Mount
Posted on: August 8, 2022

Job Description:

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1200 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.
Due to constant growth, PQE is looking for Validation Engineer in Rocky Mount, NC. The role will be onsite for a 9-month contract with a possibility of extension.
Responsibilities:
--- Support project activities within a cross-functional project team. --- Perform verification activities to support HVAC system start-up and verification. --- Perform verification activities to support the Process control systems associated with WFI 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 engineering, science or related field. --- At least 5 years of experience in qualification activities for Pharmaceutical Industries.--- 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 elaboration and execution of FAT, Commissioning, SAT, Installation Qualification, Operational Qualification and Performance Qualification Protocols and Qualification Reports. --- Hands on experience related to HVAC systems commissioning and qualification. --- Experience on handling instruments necessary to support HVAC qualification tests. --- 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. --- Support the elaboration of Standard Operating Procedures. --- 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 , Validation Engineer, Engineering , Rocky Mount, North Carolina

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