Downstream CQV Engineer - Onsite GMP Validation & Startup

Piper Companies

Holly Springs (NC)

On-site

USD 103,000 - 117,000

Full time

5 days ago
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Benefits offered by this job

Medical Benefits
Dental Benefits
Vision Benefits
401K

Job summary

Piper Companies is seeking a Downstream CQV Engineer for a 6-month contract onsite in Holly Springs, NC. The role focuses on commissioning, qualification, and verification across new and existing downstream manufacturing buildings in a biopharmaceutical setting.

Responsibilities include IQ/OQ/PQ execution, field verification, and documentation management. DeltaV systems experience is preferred, with emphasis on on-site, hands-on qualification activities in a regulated environment.

Qualifications

  • 2–5 years of experience qualifying large-scale equipment in a regulated environment.
  • Experience supporting downstream manufacturing operations such as buffer preparation, chromatography, UF, or bulk fill/dispense.
  • Strong field execution with keen ability to apply documentation standards and best practices.

Responsibilities

  • Execute IQ/OQ/PQ for downstream process equipment and systems.
  • Perform field verification including P&ID walkdowns and system turnover.
  • Support software/automation efforts, including DeltaV-based verification.
  • Author/review/execute qualification docs while on the floor.
  • Troubleshoot equipment issues during qualification and startup activities.

Skills

IV qualification
OV qualification
PQ qualification

Tools

DeltaV system
Documentation control

Job description

Piper Companies is seeking a Downstream CQV Engineer for a 6-month contract onsite in Holly Springs, NC. The role focuses on commissioning, qualification, and verification across new and existing downstream manufacturing buildings in a biopharmaceutical setting.

Responsibilities include IQ/OQ/PQ execution, field verification, and documentation management. DeltaV systems experience is preferred, with emphasis on on-site, hands-on qualification activities in a regulated environment.

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