CQV Engineer

7 days ago

Holly Springs, North Carolina, United States PharmEng Technology Full time $80,000 - $120,000 per year


CQV Engineer - Downstream Process Equipment (Biopharma)
Employment Type: Permanent/Contract (Fulltime)

We are 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.

Key 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.
Qualifications:
  • 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.
  • 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.

  • 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.

Qualified candidates with a strong foundation in downstream processing and equipment qualification are encouraged to apply. This is an excellent opportunity to join a high-impact biopharma project and contribute meaningful expertise in a dynamic, fast-paced environment.


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