Apply on Employer Site

Validation & Engineering Group, Inc. · 2 months ago

AT01-102725 Packaging Validation Engineer SC

Greenville, SC

Full-time

Onsite

Mid, Senior Level

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. They are seeking a Packaging Validation Engineer to lead packaging qualification and validation efforts for sterile liquid filling and packaging operations, coordinating with engineering, manufacturing, and quality teams to ensure regulatory compliance.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Lead the packaging validation project, coordinating cross-functional efforts and ensuring alignment with project objectives, timelines, and regulatory requirements

Develop and execute validation documentation (URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and final reports) for packaging lines and related equipment, including fillers, cappers, labelers, conveyors, vision inspection, and serialization systems

Manage communication between validation, engineering, and quality teams to drive efficient decision-making and issue resolution

Oversee qualification of change parts, line configuration changes, and multiple bottle/cap presentations

Provide hands-on support during commissioning and execution phases, including troubleshooting and deviation resolution

Support process performance qualification (PPQ) activities and readiness for commercial production

Ensure all validation deliverables comply with cGMP, FDA, and EU Annex 1 requirements, as well as internal procedures and the site’s Validation Master Plan (VMP)

Qualification

Packaging validationLiquid filling systemsGAMP 521 CFR Part 11Aseptic operationsSerialization systemsLeadership experienceCommunication skillsOrganizational skillsDocumentation skills