Senior Packaging Validation Engineer — Lead CQV for Packaging Line

Veg Group; Greenville (SC); On-site; USD 110,000 - 140,000; Full time

Job summary

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

The role requires coordinating validation, engineering, manufacturing, and quality, with on-site execution and global FAT involvement. The ideal candidate has 6+ years in GMP validation, hands-on Kneat experience, and strong IQ/OQ/PQ skills, along with leadership and excellent communication.

Qualifications

• Bachelor's degree in Engineering or Natural Sciences preferred.
• Minimum 6 years of experience supporting CQV or validation activities in a GMP-regulated environment.
• Hands-on Kneat experience is required; familiarity with ValGenesis, Veeva Vault Validation, or MasterControl is a plus.
• Demonstrated leadership experience in validation or engineering.
• Excellent written and verbal communication; ability to coordinate across departments.
• Experience with IQ/OQ/PQ protocol development and execution.
• Packaging validation experience preferred; strong equipment CQV in pharma/biotech also considered.
• Ability to work on-site in a fast-paced manufacturing environment.
• Willingness to travel internationally for FAT execution with valid passport.

Responsibilities

• Lead and execute equipment qualification and validation activities for packaging systems (fillers, cappers, labelers, conveyors, vision systems, serialization).
• Coordinate validation activities, ensuring alignment on priorities, sequencing, and deliverable timing.
• Serve as the validation point of contact for the packaging line and communicate status to stakeholders.
• Author, review, approve, and execute validation documentation in Kneat (IQ/OQ/PQ, FAT/SAT, risk assessments, and summary reports).
• Support validation activities for facilities, utilities, and solution preparation systems.
• Execute FAT activities at vendor/OEM facilities, including international sites, and drive punch-list resolution.
• Provide hands-on support during commissioning and qualification on the manufacturing floor.
• Support qualification of change parts and line configuration adjustments for different bottle/cap presentations.
• Drive deviation resolution and root cause investigations during validation execution.
• Ensure all validation deliverables comply with cGMP and FDA regulations.

Skills

Kneat

Packaging validation

GMP

Cross-functional coordination

Leadership

IQ/OQ/PQ

Education

Bachelor's degree in Engineering or Natural Sciences

Tools

ValGenesis

Veeva Vault Validation

MasterControl

Job description

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

The role requires coordinating validation, engineering, manufacturing, and quality, with on-site execution and global FAT involvement. The ideal candidate has 6+ years in GMP validation, hands-on Kneat experience, and strong IQ/OQ/PQ skills, along with leadership and excellent communication.