Senior Sterilization Engineer

Lead planning and execution of the sterilization workstream, delivering technical sterilization solutions for pharmaceutical products. Serve as the Delivery Systems sterilization subject matter expert, partnering with cross‑functional teams to drive sound technical decisions aligned with business goals. Act as the primary resource for sterilization activities across healthcare product R&D, including selection of appropriate technologies and oversight of validation efforts to ensure robust, compliant, and regulatory‑aligned processes.

Responsibilities Include:

• Lead the design and implementation of sterilization strategies to ensure medical devices meet performance and design requirements.
• Conduct risk evaluations and validation activities to confirm the safety and effectiveness of sterilization processes.
• Establish, maintain, and continuously improve sterilization processes in alignment with regulatory and industry standards.
• Partner with R&D, Quality Engineering, and cross‑functional teams to protect product integrity during new product launches, lifecycle changes, and technology transfers.
• Provide expert technical guidance on sterilization processes and regulatory expectations to both internal teams and external partners.
• Review and trend sterilization data to identify patterns and drive continuous process improvements.
• Diagnose and resolve sterilization equipment and process issues in a timely and effective manner.
• Support internal and external audits by ensuring compliance and recommending opportunities for improvement.
• Train and mentor R&D teams on sterilization methodologies, procedures, and regulatory requirements.
• Oversee the qualification, validation, and ongoing maintenance of sterilization equipment to meet operational and efficiency goals.
• Identify and lead process optimization initiatives and cost‑reduction opportunities within sterilization systems.
• Prepare and manage regulatory submissions and respond to agency inquiries related to sterilization activities.
• Communicate project status, milestones, and timelines to leadership and core team members.
• Ensure consistent adherence to company compliance, safety, and quality policies.

Ideal Skillset:

• Bachelor's degree in chemical engineering, microbiology, or related
• 4+ years of experience in sterilization development for life science products
• Demonstrated experience managing CAPAs, nonconformances, deviations, and complaint investigations, including preparation of product evaluation reports and regulatory notifications to competent authorities.
• Proven ability to lead sterilization development initiatives across the full product lifecycle, from early concept through commercial launch.