Ecocareers ยท 2 months ago
Packaging Validation Engineer
Greenville, SC
Full-time
Onsite
Senior LevelEcocareers is a confidential company seeking a Packaging Validation Engineer. The role involves leading packaging validation projects, ensuring compliance with regulatory requirements, and managing cross-functional communication to support efficient decision-making and issue resolution.
Staffing & Recruiting
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, labellers, 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
Required
Bachelor's 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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase