Role: Sr. CQV Engineer

Duration: 12 Months on W2

Location: Rocky Mount, NC

Must have : Pharma Industry Exp, Water for Injection (WFI), CQV, DI-PW-WFI systems, SCADA , CSV , FAT , SAT, Water Pretreatment systems,

Our client seeks a highly skilled Senior CQV (Commissioning, Qualification, and Validation) Engineer specializing in Deionized Water Pretreatment Systems and distribution networks, with at least 8 years of relevant experience.

Key Responsibilities:

• Lead and execute CQV for Deionized Water Pretreatment Systems, including developing and implementing IQ, OQ, and PQ protocols.
• Conduct risk assessments, troubleshoot systems, and ensure proper documentation and traceability throughout the process.
• Manage CQV and CSV projects from initiation to completion, coordinating with stakeholders and presenting project status reports.
• Validate control systems such as SCADA and PLCs, ensuring compliance with GMP, FDA, and regulatory requirements.
• Conduct audits and inspections, implement quality assurance processes, and manage project documentation.
• Train and mentor junior engineers and technicians, and develop and approve User Requirement Specifications and Validation Plans.
• Follow up on vendor testing, issue commissioning documents, and prepare and approve Installation and Performance Qualification Reports.
• Verify construction turnover packages, material certificates, welding documentation, slope checks, piping, and insulation.
• Design Deionized Water Pretreatment Systems and infrastructure.
• Create and review engineering drawings, P&IDs, and specifications.

Qualifications:

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or related field).
• Minimum of 8 years of CQV experience focused on Deionized Water Pretreatment systems and related networks.
• Strong knowledge of GMP, FDA, and regulatory requirements.
• Excellent project management, problem-solving, and communication skills.
• Proficiency in design engineering for Deionized Water systems.

Preferred Skills:

• Experience in pharmaceutical or biotech manufacturing environments.
• Certification in Project Management (PMP) or CQV.
• Experience with risk-based integrated CQV approaches.