Senior Packaging CQV Engineer – GMP Validation Lead

Pinnaql; South Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group Inc V&EG a Pinnaql company seeks a Senior CQV Packaging Validation Engineer to lead qualification and validation for a new packaging line handling liquids in multiple bottle and cap configurations.

The role requires coordinating with validation, engineering, manufacturing and quality, ensuring adherence to cGMP and FDA guidelines while supporting related facilities utilities validation as needed. On-site work is required.

Qualifications

• Bachelor's degree in Engineering or Natural Sciences preferred.
• Minimum 6 years of experience in CQV/validation in GMP environment.
• Hands-on Kneat experience is required.
• Familiarity with ValGenesis, Veeva Vault, or Validation MasterControl and ability to ramp up on Kneat.
• Demonstrated leadership in validation or engineering roles.
• Excellent written and verbal communication; able to coordinate across departments.

Responsibilities

• Lead and execute qualification and validation activities for packaging systems (fillers, cappers, labelers, conveyors, vision, serialization).
• Coordinate validation priorities, sequencing, and deliverables with stakeholders.
• Act as the validation point of contact for the packaging line; report status, risks, and issues.
• Prepare and execute validation documentation (IQ/OQ/PQ, FAT, risk assessments, etc.).
• Support validation for facilities utilities and solution preparation systems as needed.
• Perform FAT at vendor/OEM sites including international locations; resolve punch lists.
• Provide hands-on support during commissioning and qualification activities on the floor.
• Validate change parts and line configurations for different bottle/cap configurations.
• Drive deviations, root-cause analysis, and documentation updates.

Skills

Kneat

Packaging validation

CQV

GMP

IQOQPQ

Validation lifecycle

Equipment qualification

Education

Bachelor's degree in Engineering or Natural Sciences

Tools

Kneat

ValGenesis

Veeva Vault

Validation MasterControl

Job description

Validation & Engineering Group Inc V&EG a Pinnaql company seeks a Senior CQV Packaging Validation Engineer to lead qualification and validation for a new packaging line handling liquids in multiple bottle and cap configurations.

The role requires coordinating with validation, engineering, manufacturing and quality, ensuring adherence to cGMP and FDA guidelines while supporting related facilities utilities validation as needed. On-site work is required.