AT01-102725 Packaging Validation Engineer SC

Validation & Engineering Group • Greenville, SC

55d • Onsite

About The Position

We are seeking a Packaging Validation Engineer with strong leadership and communication skills to lead packaging qualification and validation efforts for sterile liquid filling and packaging operations in Greenville, SC. The selected professional will coordinate and execute all CQV activities related to a new packaging line handling liquid products in multiple bottle and cap configurations, working closely with client engineering, manufacturing, and quality teams to ensure project success and regulatory compliance.

Requirements

• Bachelors degree in Engineering or Natural Sciences.
• Experience in packaging validation for sterile or aseptic liquid operations.
• Demonstrated experience leading validation projects or small technical teams.
• Solid understanding of liquid filling systems, packaging automation, inspection technologies, and capping mechanisms.
• Strong knowledge of GAMP 5, 21 CFR Part 11, and Annex 1.
• Excellent communication, organization, and documentation skills, with the ability to effectively interact with clients, peers, and management.
• Ability to work independently and manage multiple priorities in a fast-paced, regulated environment.

Nice To Haves

• Experience leading packaging validation for sterile liquids or biologics.
• Familiarity with serialization and aggregation systems.
• Previous client-facing or project leadership experience within pharmaceutical or biotechnology manufacturing.

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 sites Validation Master Plan (VMP).

What This Job Offers

• Career Level: Mid Level
• Industry: Personal and Laundry Services
• Number of Employees: 101-250 employees