Senior Process Engineer

The Senior Process Engineer will serve as a technical owner for isolator-based systems and Grade A containment environments, supporting implementation, qualification, and lifecycle optimization of aseptic processing infrastructure.

The position is well-suited for an engineer with deep hands-on experience in isolator systems, decontamination technologies, and sterile manufacturing controls who is looking to become a recognized subject matter expert and technical lead.

• Provide technical ownership for isolator-based aseptic processing systems, including qualification strategy, lifecycle management, and regulatory alignment.
• Lead development and execution of decontamination and sterilization strategies (e.g., VHP, SIP, CIP, autoclave cycles) for containment systems and associated material/personnel transfer solutions.
• Design, execute, and document engineering studies to establish isolator operating envelopes, airflow control strategies, pressure cascades, and material transfer workflows.
• Author and review qualification protocols and reports (DQ, IQ, OQ, PQ), aseptic process simulations, and system requalification packages for containment environments.
• Conduct risk assessments and process FMEAs focused on aseptic operations, isolator failure modes, and contamination control strategies.
• Serve as technical lead during investigations and deviations related to sterile processing equipment, environmental excursions, and containment system failures.
• Partner with automation, facilities, and quality teams to evaluate and implement upgrades to isolators, barrier systems, and environmental control architectures.
• Support technology transfer activities by defining containment process requirements, reviewing batch documentation, and ensuring robust aseptic processing strategies are in place.
• Interface with equipment vendors and integrators to define URS/FRS, review design packages, and support FAT/SAT activities for new isolator installations.
• Mentor junior engineers and manufacturing personnel on aseptic best practices, containment principles, and regulatory expectations for sterile manufacturing systems.

• Bachelor’s degree or higher in Chemical, Mechanical, Biomedical, or related Engineering discipline.
• 5+ years of experience in sterile pharmaceutical manufacturing or other GMP-regulated environments, with demonstrable exposure to aseptic processing equipment.
• Hands-on experience with isolators, RABS, or other containment technologies in a manufacturing or engineering capacity.
• Working knowledge of sterilization and decontamination technologies, including VHP, autoclaves, and clean steam systems.
• Experience with qualification, validation, and lifecycle management of critical manufacturing equipment.
• Ability to work cross-functionally in a regulated manufacturing environment and communicate technical concepts to non-technical stakeholders.