Downstream CQV Engineer - 175521 - 175629

Piper Companies; Holly Springs (NC); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Vision benefits

Dental benefits

PTO

Paid Holiday

Sick Leave

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Field execution

CQV experience

GMP knowledge

Education

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

Job description

Piper Companies is seeking a Downstream CQV Engineer to support a growing client in the biologics manufacturing industry in Holly Springs, NC. The Downstream CQV Engineer role requires working onsite full-time within a greenfield biologics manufacturing facility. The Downstream CQV Engineer role is ideal for a hands-on engineering professional with 2-5 years of experience supporting commissioning, qualification, and validation activities, with a strong focus on field execution and IQ/OQ/PQ protocols.

Responsibilities of the Downstream CQV Engineer include:

• Execute commissioning, qualification, and validation activities for downstream process equipment and supporting systems within a biologics manufacturing environment.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol execution, documentation, and troubleshooting.
• Partner closely with engineering, manufacturing, quality, and project teams to ensure systems are transitioned effectively from construction through qualification.
• Support field verification activities, walkdowns, punch list resolution, and turnover package reviews during startup and commissioning phases.
• Ensure all CQV activities are conducted in compliance with GMP requirements, site procedures, and regulatory expectations.

Requirements of the Downstream CQV Engineer include:

• 2-5 years of experience supporting CQV activities within pharmaceutical, biotech, or life sciences manufacturing environments.
• Hands-on experience executing IQ, OQ, and PQ protocols for process equipment, utilities, or manufacturing systems.
• Strong field execution background with the ability to work directly on the manufacturing floor during startup and qualification activities.
• Familiarity with GMP regulations, validation lifecycle principles, and commissioning best practices.
• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

Compensation for the Downstream CQV Engineer include:

• $110,000 - $130,000 annually
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
• Opportunity to support a large-scale greenfield biologics manufacturing startup project.

Keywords: Downstream CQV Engineer, Commissioning Engineer, Validation Engineer, Qualification Engineer, CQV, Commissioning, Qualification, Validation, IQ, OQ, PQ, GMP, Biologics, Biotechnology, Pharmaceutical Manufacturing, Process Equipment, Greenfield, Startup Facility, Holly Springs, North Carolina

#LI-BM4 #LI-ONSITE