Job Description

Job Title: Scientist – Container Closure Integrity (CCI)

Location: 100% Onsite – Lab-Based Role

Team: Device Product & Process Development (DPPD)

Department: Research Labs, Combination Product Development

Shift: Standard Day Shift

Role Overview:

The Scientist will support the development, validation, and execution of Container Closure Integrity Testing (CCIT) methods for biologics, small molecules, and vaccine combination products. Working closely with cross-functional teams, this role ensures that packaging and delivery systems meet GMP and regulatory standards for sterility, integrity, and performance across various device platforms including vials, syringes, cartridges, and injectors .

Key Responsibilities:

• Develop and validate CCI test methods aligned with USP <1207> and regulatory expectations
• Execute feasibility and routine testing using techniques such as vacuum decay, dye ingress, high voltage leak detection, laser headspace analysis, and helium leak testing
• Author and review technical documents, including protocols and technical reports
• Ensure compliance with GMP/GxP standards and contribute to tech transfers between Quality Control labs
• Support cross-functional collaboration with engineering, quality, regulatory, and manufacturing teams
• Participate in risk identification and mitigation activities related to container integrity

Required Qualifications & Skills:

• B.S./M.S. in Mechanical Engineering, Biomedical Engineering, Analytical Chemistry, Pharmaceutical Sciences, or related fields
• 0–1 years of relevant experience in pharmaceuticals, biotechnology, or medical devices
• Understanding of CCI principles and basic laboratory skills in method development and validation
• Ability to write clear technical documentation and work collaboratively
• Strong attention to detail, organizational skills, and time management

Preferred Skills & Experience:

• Experience working in GMP-regulated environments with large molecules
• Hands-on expertise in CCI technologies and test method troubleshooting
• Exposure to Instron, XRCT, rheometers, microscopy, and metrology tools
• Familiarity with auto-injectors, on-body injectors , and other combination devices
• Strong communication and interpersonal skills

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