Onsite Downstream CQV Engineer - Biologics Startup

ZP Group

Holly Springs (NC)

On-site

USD 110,000 - 130,000

Full time

4 days ago
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Benefits offered by this job

Health insurance
Vision coverage
Dental coverage
Paid time off
Paid holidays

Job summary

Piper Companies is seeking a Downstream CQV Engineer in Holly Springs, NC, to execute CQV activities on a greenfield biologics startup. The role emphasizes hands-on field work, IQ/OQ/PQ protocol execution, and strict GMP adherence on-site.

The ideal candidate brings 2-5 years of CQV experience in pharma or biotech, with a strong track record on process equipment and utilities, and a engineering/life sciences background. This full-time onsite position offers comprehensive benefits.

Qualifications

  • 2-5 years of experience supporting CQV activities in pharma, biotech, or life sciences manufacturing.
  • Hands-on experience executing IQ, OQ, and PQ protocols for equipment, utilities, or systems.
  • Strong field execution background to work directly on the manufacturing floor during startup/qualification.
  • Familiarity with GMP regulations, validation lifecycle principles, and commissioning best practices.

Responsibilities

  • Execute commissioning, qualification, and validation activities for downstream process equipment and supporting systems.
  • Perform IQ, OQ, and PQ protocol execution, documentation, and troubleshooting.
  • Partner with engineering, manufacturing, quality, and project teams to ensure smooth transitions from construction to qualification.
  • Support field verification activities, walkdowns, punch list resolution, and turnover package reviews during startup.
  • Ensure all CQV activities comply with GMP and site procedures.

Skills

CQV execution
GMP compliance
On-site startup
Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

IQ/OQ/PQ protocols

Job description

Piper Companies is seeking a Downstream CQV Engineer in Holly Springs, NC, to execute CQV activities on a greenfield biologics startup. The role emphasizes hands-on field work, IQ/OQ/PQ protocol execution, and strict GMP adherence on-site.

The ideal candidate brings 2-5 years of CQV experience in pharma or biotech, with a strong track record on process equipment and utilities, and a engineering/life sciences background. This full-time onsite position offers comprehensive benefits.

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