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
Ability to work independently and manage multiple priorities in a fast-paced, regulated environment
Responsibilities
Lead the packaging validation project, coordinating cross-functional teams
Develop and execute validation documentation for packaging lines and equipment
Manage communication between validation, engineering, and quality teams
Oversee qualification of change parts and line configuration changes
Provide hands-on support during commissioning and execution phases
Support process performance qualification activities for commercial production
Ensure compliance with cGMP, FDA, and EU Annex 1 requirements
Full Job Description
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).
Requirements:
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.
bility to work independently and manage multiple priorities in a fast-paced, regulated environment.
