System Owner Engineer - Aseptic Filling Systems

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. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• System Owner Engineer - Aseptic Filling Systems

Position Summary

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.

Key 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.

Qualifications

• 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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.