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.

RESPONSIBILITIES:

• 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.
• Ensure compliance with GMP, regulatory, safety, and engineering standards throughout all project phases.
• Collaborate with Quality, Validation, Manufacturing, Maintenance, and Operations teams to ensure successful project delivery and ongoing operational performance.

QUALIFICATIONS AND REQUIREMENTS:

• Degree or Diploma in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
• P.Eng designation or eligibility for professional registration is preferred.
• Minimum 10 years of engineering and project management experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Demonstrated experience leading capital projects, equipment installations, production line expansions, and facility retrofit initiatives.
• Strong knowledge of aseptic filling, packaging, sterilization systems, and sterile manufacturing operations.
• Experience working in GMP-regulated cleanroom environments, including contamination control, environmental monitoring, and Grade A/B aseptic processing.
• Practical experience with Open and Closed RABS systems and aseptic manufacturing technologies.
• Experience preparing and reviewing engineering documentation, including URS, qualification protocols, and validation deliverables.
• Working knowledge of equipment qualification and validation activities including FAT, SAT, DQ, IQ, OQ, and commissioning.
• Proficiency with AutoCAD, Microsoft Project, and Microsoft Office Suite.
• Strong troubleshooting, problem-solving, project management, and cross-functional leadership skills.
• Knowledge of GMP, FDA, ISO, and regulatory compliance requirements.
• Experience working with OEMs, contractors, system integrators, and external vendors.
• Familiarity with PLC-controlled systems, automation integration, and manufacturing process equipment is considered an asset.

Compensation:

The salary range for this role is $110,000 - $145,000.

This posting is for a new position. Pillar5 Pharma does not use AI at any stage of the recruitment or hiring process. Pillar5 Pharma is committed to diversity, inclusion, and equal opportunity in the workplace. Accommodations are available upon request throughout the recruitment and selection process.