CQV Engineer - Downstream Process Equipment (Biopharma) jobs in United States
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PharmEng Technology ยท 1 week ago

CQV Engineer - Downstream Process Equipment (Biopharma)

positionHolly Springs, NC
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

PharmEng Technology is seeking a skilled CQV Engineer to support commissioning and qualification activities for downstream process equipment within a large-scale biopharmaceutical manufacturing facility. This role involves hands-on work in a startup environment and collaboration with cross-functional teams to ensure timely, compliant, and successful delivery of equipment systems.

ConsultingInformation TechnologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Support commissioning and qualification of downstream process equipment, including chromatography skids and columns, column packing systems, UF/DF systems, filtration skids, product hold vessels, and intermediate bulk fill systems
Assist with the preparation and execution of CQV documentation, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Design Qualification (DQ), Requirements Trace Matrix (RTM), Quality Risk Assessments (QRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and final reports
Participate in system startup and handover activities, supporting the full CQV lifecycle from design through to operations readiness
Conduct field walkdowns, assist in punch list resolution, and verify mechanical completion of systems
Support Pre-Startup Safety Reviews and safe execution of startup activities
Ensure accurate documentation, traceability, and alignment with ASTM E2500 and project quality standards
Coordinate with scheduling and project teams to ensure proper sequencing and readiness of downstream process systems

Qualification

CQV experienceDownstream processingChromatographyDeltaVCQV documentation toolsEngineering backgroundCollaborative teamwork

Required

Minimum 5 years of CQV experience in biopharmaceutical manufacturing environments, with a focus on downstream processing systems
Strong technical understanding of chromatography, UF/DF systems, filtration, and stainless-steel process equipment
Proven ability to work collaboratively in cross-functional teams, including EPCM, automation, QA, and operations
Willingness and ability to travel as required for equipment acceptance testing and support

Preferred

Engineering background in Chemical or Mechanical disciplines preferred
Experience with DeltaV or similar process control systems, including troubleshooting and loop tuning
Familiarity with CQV documentation tools such as Kneat or equivalent

Company

PharmEng Technology

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PharmEng Technology is a pharmaceutical company that provides consultancy services.
dateFounded in 1997
location
Toronto, Ontario, CAN
people-size201-500 employees
web-link
http://pharmeng.com

H1B Sponsorship

PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

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Alan Kwong
Managing Director & CEO
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Company data provided by crunchbase