Aseptic Validation Engineer Onsite 12-Month Contract

System One, Inc.; Athens (GA); On-site; USD 62,000 - 66,000; Full time

Benefits offered by this job

medical

dental

vision

spending accounts

life insurance

voluntary plans

participation in a 401(k) plan

Job summary

System One, Inc. in Athens, GA is seeking an Aseptic Manufacturing Validation Engineer for a 12-month contract onsite. You will support aseptic manufacturing system validation activities and contribute to qualification documentation in a cGMP environment.

You will execute validation for autoclaves, depyrogenation tunnels, filling lines, HVAC systems, and other utilities, writing protocols and final reports while collaborating with Engineering, Maintenance, and Production teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• Experience performing validation activities in a cGMP-regulated pharma/biopharma or biotech environment.
• Knowledge of aseptic processing, sterilization, cleaning validation, smoke studies, media fills, and equipment qualification methods.

Responsibilities

• Execute validation and qualification activities for autoclaves, depyrogenation tunnels, filling lines, HVAC systems, cold rooms, freezers, warehouses, and pharmaceutical utilities.
• Perform smoke studies, support media fill qualifications, and provide SME for aseptic processing validation.
• Author and execute validation protocols, periodic reviews, qualification documents, and final reports.
• Support change controls, deviations, CAPAs, risk assessments, and development of validation lifecycle documentation including URS, FRS, and design qualification deliverables.
• Partner with Engineering, Maintenance, and Production teams to support equipment selection, upgrades, compliance readiness, and regulatory inspections.

Skills

Validation execution

Documentation

cGMP knowledge

Cross-functional collaboration

Aseptic processing knowledge

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Ellab data loggers

Job description

System One, Inc. in Athens, GA is seeking an Aseptic Manufacturing Validation Engineer for a 12-month contract onsite. You will support aseptic manufacturing system validation activities and contribute to qualification documentation in a cGMP environment.

You will execute validation for autoclaves, depyrogenation tunnels, filling lines, HVAC systems, and other utilities, writing protocols and final reports while collaborating with Engineering, Maintenance, and Production teams.