Drug Product and Device Sterilization Technical Lead

Job Description

Job Description

Who Our Client Is :

Our client is a mission-driven healthcare organization focused on advancing innovation, improving patient outcomes, and strengthening communities. They believe that diversity fuels creativity, collaboration, and success. By fostering an inclusive workplace where every voice is valued, respected, and empowered, they create an environment where people can thrive both personally and professionally.

What Our Client Needs :

Our client is seeking a Drug Product and Sterilization Technical Lead to provide technical support for the UVADEX drug and sterilization of single-use kits, ensuring continued product quality, compliance, and supply reliability. This role combines expertise in drug product support with sterilization of disposable medical devices (EtO) and requires a strong understanding of combination products. The engineer will lead issue resolution, drive continuous improvement, and partner across functions to maintain compliant, robust, and efficient processes.

Who You Are :

You are a technically skilled professional with deep experience in sterile drug manufacturing, terminal sterilization, and process validation. You excel at solving complex problems, managing documentation in regulated environments, and collaborating across teams to maintain product quality and compliance. You are driven by precision, continuous improvement, and operational excellence in both drug and device processes.

What You’ll Do :

• Provide technical engineering support for UVADEX drug.
• Provide sustaining and continuous improvement for sterilization processes of both drug and disposable / single-use kits (EtO).
• Lead issue resolution related to drug / device interactions, sterilization, and product performance.
• Support drug product technical transfers, including production line and room qualifications.
• Support EtO sterilization validations, revalidations, and material compatibility studies.
• Partner with Quality, Manufacturing, and Regulatory to ensure compliance with FDA, EMA, and ISO requirements.
• Drive continuous improvement initiatives across drug and device processes.
• Collaborate with suppliers and contract manufacturers to resolve technical challenges.
• Support lifecycle management, design changes, and risk assessments for drug and kit components.
• Prepare technical documentation, validation protocols, and reports in compliance with cGMP and ISO 13485.

This position requires minimal travel and has no supervisory responsibilities.

What You’ll Need :

What They Offer :

Equal Opportunity Statement :

Our client believes that diversity fuels innovation, strengthens teams, and drives success. They are committed to fostering a workplace where every individual—regardless of background—feels valued, respected, and empowered to thrive.

Discrimination or harassment of any kind is strictly prohibited.

Our client does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by applicable laws. Their commitment extends beyond compliance; they actively cultivate an inclusive culture where diverse perspectives are welcomed, and every employee has an equal opportunity to contribute and succeed.