System Owner: Aseptic Filling Systems Engineer

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a System Owner Engineer for aseptic filling systems in a biotech/pharmaceutical facility.

You will be the technical owner for assigned equipment, collaborating with Engineering, Manufacturing, Maintenance, Automation, Quality and Validation teams to ensure reliable operations. Responsibilities include supporting vial and syringe filling operations, commissioning, qualification, change controls, CAPAs, and maintaining documentation, drawings, SOPs,

Qualifications

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

Responsibilities

• Serve as System Owner for aseptic filling equipment and related 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 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, 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.

Skills

Cross-functional collaboration

Ownership mindset

Education

Bachelor’s degree in Engineering or related technical discipline

Tools

Isolators

Aseptic processing environments

Vial and prefilled syringe systems

Job description

Validation & Engineering Group, Inc. is seeking a System Owner Engineer for aseptic filling systems in a biotech/pharmaceutical facility.

You will be the technical owner for assigned equipment, collaborating with Engineering, Manufacturing, Maintenance, Automation, Quality and Validation teams to ensure reliable operations. Responsibilities include supporting vial and syringe filling operations, commissioning, qualification, change controls, CAPAs, and maintaining documentation, drawings, SOPs,