CQV Engineer (Onsite/W2)

Highbrow Technology Inc; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Highbrow Technology Inc. in North Carolina (RTP area) seeks a skilled CQV validation consultant to perform in-field verification and commissioning for upstream and downstream pharma processing equipment.

You will verify P&IDs, datasheets, and vendor drawings, conduct turnover reviews, and drive system readiness with related documentation. Responsibilities include executing CQV activities on bioreactors, chromatography skids, UF/DF systems, viral filtration, and associated buffers.

Qualifications

• Previous experience performing validation (CQV) in a large-scale pharma/life science facility.

Responsibilities

• Field verification (physical inspection) of P&IDs, equipment datasheets, vendor drawings, isometrics, utility connections, and system boundaries.
• Perform system completion walkdowns and turnover package reviews to verify construction readiness, punch list closure, weld documentation, calibration records, and redlines.
• Executing commissioning and qualification activities for upstream processes including bioreactors, media prep systems, incubators, pumps, centrifuges.
• Executing commissioning and qualification activities for downstream process equipment including chromatography skids, ultrafiltration/diafiltration (UF/DF) systems, viral filtration skids, depth filtration systems, buffer preparation vessels, and product hold tanks.
• Field verification and startup testing of chromatography systems: flow path verification, valve sequencing, conductivity monitoring, pressure monitoring, and automation functionality checks.
• Verify process alarms, interlocks, emergency shutdown functions, and automation sequences through field testing and control system verification activities.
• Execute OQ for automated systems using DeltaV, including loop checks, I/O verification, valve sequencing, interlock testing, alarm challenges, and control logic verification under live conditions.
• Identify and resolve startup issues involving automation logic, valve sequencing, cleaning cycle performance, and skid-to-system interfaces.

Skills

CQV validation

Pharma equipment

DeltaV OQ

Field verification

P&ID review

automation logic

Upstream/downstream

Tools

MS Office

Smartsheet

Kneat

Job description

Location: Onsite in North Carolina - the RTP area

• Client is completing construction of two more DSM units and will be executing final CQV of all equipment, both upstream and downstream.
• Focus is going to be operational C&Q of process equipment, automation and associated utilities.
• In field verification of all relevant documentation (P&ID’s, data sheets, drawings, etc)
• Identification and resolution of startup issues along with any required documentation

Technology environment the consultant will be working in

• MS Office
• Smartsheet
• Kneat

Consultants day to day responsibilities:

• Field verification (physical inspection) of P&IDs, equipment datasheets, vendor drawings, isometrics, utility connections, and system boundaries. (Verifying designs match as-built)
• Perform system completion walkdowns and turnover package reviews to verify construction readiness, punch list closure, weld documentation, calibration records, and redlines.
• Executing commissioning and qualification activities for upstream processes including bioreactors, media prep systems, incubators, pumps, centrifuges.
• Executing commissioning and qualification activities for downstream process equipment including chromatography skids, ultrafiltration/diafiltration (UF/DF) systems, viral filtration skids, depth filtration systems, buffer preparation vessels, and product hold tanks.
• Field verification and startup testing of chromatography systems: flow path verification, valve sequencing, conductivity monitoring, pressure monitoring, and automation functionality checks.
• Verify process alarms, interlocks, emergency shutdown functions, and automation sequences through field testing and control system verification activities.
• Execute OQ for automated systems using DeltaV, including loop checks, I/O verification, valve sequencing, interlock testing, alarm challenges, and control logic verification under live conditions.
• Identify and resolve startup issues involving automation logic, valve sequencing, cleaning cycle performance, and skid-to-system interfaces.

Required Skills:

• Previous experience performing validation (CQV) in a large-scale pharma/life science facility
• Examples of required equipment: bioreactors, pumps, centrifuges, UF Skids, chromatography systems, viral filtration systems, buffer prep/hold tanks.
• System walkdowns, TOP review, punch list review, calibration record review
• Identifying automation logic, valve sequencing, cleaning cycle issues.
• Prior experience executing validation activities in a stainless steel and large molecule environment.
• Previous experience executing CQV activities on upstream and/or downstream process equipment.
• Prior experience doing field verification of P&ID’s, equipment data sheets and vendor drawings.
• Prior experience executing OQ activities for the automated systems using DeltaV

Desired Skills:

• Process engineer experience (upstream or downstream)