Downstream CQV Engineer: Biologics Startup Onsite

Piper Companies; Holly Springs (NC); Vor Ort; USD 110.000 - 130.000; Vollzeit

Benefits dieser Stelle

Health benefits

Vision benefits

Dental benefits

PTO

Paid Holiday

Sick Leave

Zusammenfassung

Piper Companies is seeking a Downstream CQV Engineer to support a growing biologics manufacturing facility in Holly Springs, NC. This onsite, full-time role focuses on commissioning, qualification and validation activities on downstream process equipment and supporting systems.

The ideal candidate has 2-5 years of CQV experience, hands-on IQ/OQ/PQ protocol execution, and a strong field execution background on the manufacturing floor.

Qualifikationen

• 2-5 years of CQV experience in pharma, biotech, or life sciences.
• Hands-on IQ, OQ, PQ protocol execution on process equipment.
• Strong field execution on the manufacturing floor during startup.
• Familiar with GMP regulations and validation lifecycles.
• Bachelor's degree in Engineering, Life Sciences, or related field.

Aufgaben

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

Kenntnisse

Field execution

CQV experience

GMP knowledge

Ausbildung

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

Jobbeschreibung

Piper Companies is seeking a Downstream CQV Engineer to support a growing biologics manufacturing facility in Holly Springs, NC. This onsite, full-time role focuses on commissioning, qualification and validation activities on downstream process equipment and supporting systems.

The ideal candidate has 2-5 years of CQV experience, hands-on IQ/OQ/PQ protocol execution, and a strong field execution background on the manufacturing floor.