Senior Engineer

Role Summary

Senior Engineer responsible for development, validation, qualification, and transfer of container closure integrity test methods for combination products and primary containers, ensuring sterility throughout the container lifecycle and supporting product filings, qualification of manufacturing processes, and routine stability studies. May telecommute.

Responsibilities

• Work with a team of engineers in the development, validation, qualification and transfer of CFR Part 11 (21 CFR 11) compliant physical test methods for container closure integrity of combination products and primary containers; ensure sterility from filling to transportation and storage to reach patients safely.
• Act as a subject matter expert on Container Closure Integrity Testing to support product filings, qualification of manufacturing processes, and maintenance of routine stability studies.
• Design, develop, and calibrate fixtures for vacuum decay testing of vials using ASTM F2338 compliant detectors and tools such as PTI-325/PTI-440, using SolidWorks.
• Develop, validate and transfer physical test methods for deliverable volume testing of primary containers per USP 697 and GMP.
• Collaborate with industry experts to advance innovative system integrity methods such as helium leak detectors, Wilcomat leak detectors, high voltage leak detection and other emerging technologies.
• Serve as a domain expert for Strength of Materials, Material Selection, fluid mechanics/mass spectrometry, and transport phenomena.
• Act as principal author for test method documentation including technical method instructions, operational protocols, equipment qualification, SOPs, and technical drawings related to equipment function.

Qualifications

• Required: Master’s degree or foreign equivalent in Mechanical Engineering, Biomedical Engineering or related field; completion of a university-level course, research project, internship, thesis, or one year of experience in container closure integrity testing and related processes.
• Required: Knowledge of 21 CFR Part 11, Good Manufacturing Practices, USP 697 and USP 1207.
• Required: Develop operational procedures and maintenance protocols for CCC test equipment including vacuum decay, helium leak detection, tracer liquid, and high voltage leak detection technologies.
• Required: Equipment validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Required: SolidWorks and MS Office Suite.
• Required: Domain knowledge in Strength of Materials, Material Selection and fluid mechanics.