Senior Packaging CQV Engineer — Lead Packaging Validation

Validation & Engineering Group, Inc.; Greenville (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Senior CQV / Packaging Validation Engineer to lead qualification and validation for a new liquid packaging line.

The role requires coordinating validation, engineering, manufacturing, and quality teams on packaging systems and related facilities as needed. The candidate will drive FAT/SAT, IQ/OQ/PQ development, risk assessments, and summary reports, with international travel for FAT execution and on-site work in a fast-paced pharmaceutical

Qualifications

• Bachelor's degree in Engineering or Natural Sciences is required.
• Minimum 6 years of experience supporting CQV or validation activities in a GMP-regulated environment.
• Hands-on Kneat experience is required; other electronic validation platforms may be considered.
• Demonstrated leadership experience in validation or engineering.
• Excellent written and verbal communication skills with cross-functional coordination.
• Experience with IQ/OQ/PQ protocol development and execution.

Responsibilities

• Lead and execute equipment qualification and validation activities for packaging systems (fillers, cappers, labelers, conveyors, vision systems, serialization).
• Coordinate validation activities, aligning priorities, sequencing, and deliverables.
• Serve as validation point of contact for the packaging line and communicate status to stakeholders.
• Prepare and review validation documentation (IQ/OQ/PQ, FAT/SAT, risk assessments, summaries).
• Support validation activities for facilities, utilities, and solution preparation systems as needed.
• Perform FAT at vendor/OEM sites, including international locations, resolving punch-list items prior to shipment.
• Provide hands-on support during commissioning and qualification on the manufacturing floor.
• Drive deviation resolution and root-cause investigations.
• Ensure all deliverables comply with cGMP, FDA regulations, and site procedures.

Skills

Leadership experience

Communication skills

Project coordination

GMP/regulatory understanding

Education

Bachelor's degree in Engineering or Natural Sciences

Tools

Kneat

ValGenesis

Veeva Vault Validation

MasterControl

Job description

Validation & Engineering Group, Inc. is seeking a Senior CQV / Packaging Validation Engineer to lead qualification and validation for a new liquid packaging line.

The role requires coordinating validation, engineering, manufacturing, and quality teams on packaging systems and related facilities as needed. The candidate will drive FAT/SAT, IQ/OQ/PQ development, risk assessments, and summary reports, with international travel for FAT execution and on-site work in a fast-paced pharmaceutical