Job Description

LTTS India
Chennai

:


Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and related guidelines. Manage packaging documentation including DHF, DMR, and validation records. Support continuous improvement initiatives in packaging processes and materials. Interface with external testing labs and suppliers to coordinate validation activities.


Required Qualifications:

Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field. 3-6 years of experience in medical device packaging, with a strong emphasis on validation and seal integrity testing. In-depth knowledge of ISTA and ASTM test standards (e.g., ASTM F88, F1929, D4169). Familiarity with ISO 11607 and other global packaging regulations. Proficient in developing test protocols, analyzing data, and writing technical reports. Strong analytical skills and problem-solving abilities. Experience working in a regulated environment (FDA, ISO). Excellent communication and cross-functional collaboration skills.


Preferred Qualifications:

Advanced degree (MS) in a relevant field. Experience with packaging equipment validation (IQ/OQ/PQ). Knowledge of statistical tools and software (e.g., Minitab, JMP). Understanding of sterilization methods (EtO, gamma, etc.) and how they impact packaging materials.

Job Requirement

packaging validation, medical devices