Sr. Fill Finish Process Engineer (Future Opportunities)

Role: Senior Fill–Finish Process Engineer supporting aseptic biologics manufacturing, focusing on the development and commissioning of a new commercial fill–finish suite. Responsibilities include design support, equipment specification, FAT/SAT, commissioning, qualification, GMP compliance, troubleshooting, process optimization, and technical documentation. The engineer partners with operations, QA, validation, engineering, and supply chain teams to ensure robust, compliant manufacturing performance aligned with FDA, EMA, and ICH standards. Requirements: Bachelor's or Master's in Chemical, Mechanical, Biomedical, or Pharmaceutical Engineering; 7+ years in GMP pharma/biotech manufacturing, with priority on sterile, biologics, or vaccine fill–finish experience; strong knowledge of aseptic processes, cleanroom environments, and equipment; excellent documentation and communication skills. Preferred: experience supporting commercial biologics or vaccine production, familiarity with digital validation platforms like KNEAT. High-value: biologics, sterile fill–finish, aseptic operations, GMP validation, regulated environments, cross-functional collaboration, and project management of engineering lifecycle activities. Work setup: primarily on-site with potential travel up to 100% based on project phase and client requirements.