Sr. Aseptic Filling Project Engineer

Pillar5 Pharma is seeking an experienced Senior Project Engineer / Senior Aseptic Filling Engineer to lead the implementation of new aseptic manufacturing and packaging capabilities within our growing sterile ophthalmic manufacturing operations.

This role is responsible for managing complex capital projects from concept through commercial production, ensuring new equipment, systems, and processes are successfully designed, installed, commissioned, validated, and transitioned into operation.

Working closely with Quality, Validation, Manufacturing, Maintenance, and Operations, the successful candidate will support the expansion of Pillar5's aseptic manufacturing capabilities while driving improvements in capacity, reliability, compliance, and operational performance.

• Lead engineering projects related to aseptic filling, packaging, sterilization systems, equipment upgrades, and facility expansion initiatives.
• Manage all phases of project execution including scope development, budgeting, scheduling, procurement, installation, commissioning, validation, startup, and handover to Operations.
• Develop and maintain project plans, ensuring alignment with operational, quality, validation, regulatory, and business requirements.
• Prepare and manage engineering documentation including URS, FDS, SOPs, work instructions, change controls, engineering assessments, and technical procedures.
• Coordinate equipment design reviews and manage relationships with vendors, contractors, suppliers, and system integrators.
• Support and oversee FAT, SAT, DQ, IQ, OQ, commissioning, and validation activities for new and modified equipment.
• Provide technical leadership and troubleshooting support for aseptic filling, packaging, sterilization, and related manufacturing systems.
• Support the implementation, operation, and optimization of aseptic processing technologies, including Open and Closed RABS systems.
• Drive continuous improvement initiatives focused on equipment reliability, efficiency, throughput, and overall equipment effectiveness (OEE).
• Participate in deviations, investigations, root cause analysis, CAPAs, and change management activities.