System Owner Engineer - Aseptic Filling Systems

Pinnaql • Guaynabo, PR

9d

About The Position

The System Owner will provide technical ownership and day-to-day support for aseptic filling equipment and associated systems within a biotech/pharmaceutical manufacturing facility. The individual will serve as the primary technical point of contact for assigned equipment and work closely with Engineering, Manufacturing, Maintenance, Automation, Quality, and Validation teams.

Requirements

• Bachelor’s degree in Engineering or related technical discipline.
• Approximately 10+ years of relevant pharmaceutical/biotech engineering or manufacturing experience preferred.
• Strong experience with aseptic filling equipment.
• Experience with vial and/or prefilled syringe systems.
• Experience with isolators and aseptic processing environments strongly preferred.
• Experience with equipment troubleshooting, qualification, change control, deviations, and GMP documentation.
• Strong communication skills and ability to work collaboratively with operations and multidisciplinary technical teams.
• Hands-on, proactive approach and strong ownership mindset.

Responsibilities

• Serve as System Owner for aseptic filling equipment and associated systems.
• Provide technical support for vial and syringe filling operations, including isolator-based systems.
• Maintain equipment in a qualified and reliable state throughout its lifecycle.
• Support equipment troubleshooting, investigations, deviations, CAPAs, and change controls.
• Coordinate maintenance, calibration, engineering, validation, and vendor activities.
• Review equipment performance and identify opportunities for reliability and operational improvements.
• Support commissioning, qualification, startup, and turnover activities as required.
• Maintain and review system documentation, drawings, specifications, SOPs, and qualification records.
• Participate in equipment walkdowns, assessments, and technical troubleshooting.
• Ensure systems remain compliant with GMP requirements and site procedures.
• Act as the technical representative for assigned systems during project and operational meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior