Aseptic Filling Systems Lead Engineer

Veg Group; Juncos (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks a System Owner Engineer for aseptic filling systems in a biotech/pharma manufacturing facility.

You will own systems, coordinate with Engineering, Manufacturing, Maintenance, Automation, Quality, and Validation to ensure compliant operation. The role requires a strong engineering background, ~10+ years in pharma/biotech, experience with isolators, aseptic processing, and GMP documentation.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 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.

Skills

Communication skills

Team collaboration

Ownership mindset

Hands-on

Education

Bachelor’s degree in Engineering

Tools

Aseptic filling equipment

Job description

Validation & Engineering Group, Inc. (V&EG) seeks a System Owner Engineer for aseptic filling systems in a biotech/pharma manufacturing facility.

You will own systems, coordinate with Engineering, Manufacturing, Maintenance, Automation, Quality, and Validation to ensure compliant operation. The role requires a strong engineering background, ~10+ years in pharma/biotech, experience with isolators, aseptic processing, and GMP documentation.