Downstream CQV Engineer - 168479

Piper Companies; Holly Springs (NC); Presencial; USD 84 000 - 129 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical benefits

Dental benefits

Vision benefits

Sick leave

401K

Resumo da oferta

Piper Companies seeks a Downstream CQV Engineer to join a biologics manufacturing organization in Holly Springs, NC, onsite for a long-term contract. You will support commissioning, qualification, and validation across downstream processing systems to ensure readiness for production in a greenfield facility.

Candidates should have 5+ years in CQV/validation within GMP, hands-on field verification, and the ability to interpret P&IDs and perform system walkdowns.

Qualificações

• 5+ years in CQV, validation, or process engineering within a GMP setting.
• Exposure to at least two phases of CQV lifecycle such as IV, OV, or PQ.
• Strong field-based experience with equipment verification and start-up.
• Ability to interpret P&ID diagrams and perform detailed system walkdowns.
• Detail-oriented and proactive mindset for troubleshooting mechanical/process systems.

Responsabilidades

• Carry out commissioning and qualification tasks across IV, OV, and PQ activities for process equipment.
• Perform hands-on system checks, field verification, and walkthroughs for validation readiness.
• Lead and assist with P&ID reviews and line walkdowns to confirm system accuracy.
• Support execution activities on downstream equipment including buffers, chromatography skids, ultrafiltration units, and bulk fill operations.
• Troubleshoot mechanical and process issues in real time with cross-functional teams.

Conhecimentos

CQV/validation

Field execution

P&ID interpretation

GMP knowledge

Troubleshooting

Ferramentas

DeltaV

HMI

Kneat

Descrição da oferta de emprego

Piper Companies is seeking a Downstream CQV Engineer to join a biologics manufacturing organization for a fully onsite, long-term contract position located in Holly Springs, NC. The Downstream CQV Engineer will play a critical role in commissioning, qualification, and validation efforts within a newly built production facility, supporting downstream processing systems and ensuring operational readiness across multiple CQV phases.

Responsibilities for the Downstream CQV Engineer include:

• Carry out commissioning and qualification tasks across Installation Verification, Operational Verification, and Performance Qualification activities for process equipment.
• Perform hands-on system checks, field verification, and walkthroughs to confirm proper installation and readiness for validation efforts.
• Lead and assist with P&ID reviews and line walkdowns to confirm system accuracy, completeness, and compliance with design intent.
• Support execution activities on downstream equipment including buffer systems, chromatography skids, ultrafiltration units, and bulk fill operations.
• Troubleshoot mechanical and process-related issues in real time while collaborating with cross-functional teams to resolve discrepancies during execution.

Qualifications for the Downstream CQV Engineer include:

• 5+ years of experience in CQV, validation, or process engineering within a regulated GMP setting.
• Exposure to at least two phases of CQV lifecycle such as IV, OV, or PQ.
• Strong field-based experience with equipment verification, system startup, and hands-on execution work.
• Ability to interpret technical diagrams, especially P&IDs, and perform detailed system walkdowns.
• Background in troubleshooting mechanical or process systems with a detail-oriented and proactive mindset.

Compensation for the Downstream CQV Engineer:

• $128,000 - $195,000 paid at an hourly rate of $61.54/hr - $93.75/hr
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 8/21/26.

Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CQV, commissioning, qualification, validation, IV, OV, PQ, downstream processing, biologics manufacturing, GMP, field execution, system verification, P&ID, walkthroughs, troubleshooting, buffer preparation, chromatography, ultrafiltration, bulk fill, DeltaV, HMI, process validation, greenfield facility, equipment startup, Kneat, validation documentation, protocol execution, utilities, clean utilities, process systems, biotech, pharma manufacturing, quality compliance, technical operations, engineering support, system readiness, operational excellence, startup environment

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