We are seeking a highly skilled and independent Commissioning, Qualification, and Validation (CQV) Engineer to join our team for a large greenfield project at our new Contract Development and Manufacturing Organization (CDMO) facility in North Carolina. This is an exciting opportunity to be part of a groundbreaking project and work with a dynamic team of professionals.
Key Responsibilities:
- Review turnover packages from vendors and construction.
- Walk systems to ensure correct installation (ability to read and walk Piping and Instrumentation Diagrams (P&IDs)).
- Operate independently after receiving direction.
- Ensure Installation Verification (IV) execution aligns with engineering specifications, CQV procedures, project strategies, and industry standards such as Bioprocessing Equipment (BPE) commissioning and validation guidelines.
- Align with CQV Turnover for the review and approval of all Turnover Packages, including Vendor Turnover Packages (VTOPs) and Construction Turnover Packages (CTOPs).
- Collaborate with the CQV (SWAT) Team on punchlist closure both pre-Mechanical Completion (pre-MC) and during the CQV execution phase for all systems related to IV execution.
- Work with all Project Groups (Design, Construction Management (CM), CQV, Automation, Process, Subject Matter Experts (SMEs), Operations (Ops), Maintenance, Project Managers (PMs)) to ensure all systems requiring IV execution are managed appropriately.
- Coordinate with System Owners (Responsible Engineers) for IV tasks, including specification deviation requests, Process Control Change (PCC) impact to test cases, and vendor documentation gaps.
- Manage timelines and needs for required IV prerequisite documents, including Vendor Data Requirements (VDRs) for IV execution, VDRs for Operational Verification (OV) execution start, Quality Assurance Manual (QAM) reports, CTOP test pack deliverables, and passivation and pressure test documentation from vendors, Construction Management Team (CMT), and Site Test Witness (STW) activities.
Qualifications:
- Proven experience in CQV engineering, particularly in greenfield projects.
- Strong understanding of P&IDs and ability to walk systems.
- Ability to work independently and manage multiple tasks.
- Excellent communication and collaboration skills.
- Familiarity with industry standards such as BPE commissioning and validation guidelines.
If this role is of interest to you, please apply now!
