Downstream CQV Engineer — Biotech GMP Startup (Onsite)

ZP Group; Holly Springs (NC); On-site; USD 76,000 - 103,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Sick leave as required by law

Job summary

Piper Companies is seeking a Downstream CQV Engineer to join a biotech manufacturing organization in Holly Springs, NC. The role supports commissioning, qualification, and validation for downstream processing equipment in a large-scale biologics environment, aiding startup and operational readiness.

Responsibilities include executing IV/OV/PQ protocols, performing field walkdowns and P&ID reviews, and maintaining GMP-compliant validation documents.

Qualifications

• 2+ years of CQV/validation experience in GMP-regulated manufacturing.
• Experience supporting at least two phases of the qualification lifecycle (IV, OV, PQ).
• Strong understanding of downstream bioprocessing equipment and operations.
• Ability to interpret P&IDs, perform system walkdowns, and troubleshoot equipment issues.

Responsibilities

• Execute IV, OV, and PQ protocols for downstream manufacturing systems.
• Perform field walkdowns, equipment inspections, and P&ID reviews to verify installation and readiness.
• Support qualification activities for downstream process equipment including chromatography, ultrafiltration, buffers, and bulk fill.
• Utilize DeltaV or similar control systems to run testing and assist with troubleshooting during commissioning and qualification.
• Prepare, review, and maintain validation documentation in line with GMP standards.

Skills

CQV experience

Validation

Process engineering

Communication skills

Tools

DeltaV

Kneat

Job description

Piper Companies is seeking a Downstream CQV Engineer to join a biotech manufacturing organization in Holly Springs, NC. The role supports commissioning, qualification, and validation for downstream processing equipment in a large-scale biologics environment, aiding startup and operational readiness.

Responsibilities include executing IV/OV/PQ protocols, performing field walkdowns and P&ID reviews, and maintaining GMP-compliant validation documents.