Validation Engineer

(phone number removed) Validation Engineer, Athens,GA 7+ months

Sigma Systems is currently looking for a Validation Engineer

Responsibilities:

Perform Smoke studies and assist in semi annual Media fill qualifications as a SME

Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.

Has worked with Ellabs data loggers and software

Write and execute protocols and complete final reports.

Understanding of cleaning validation concepts and principles.

Understands pharma grade utilities ( water HVAC, gases)

Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.

Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.

Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready " at all times.

Support Change Control, Deviation and CAPA activities

Requirements:

Bachelors , preferable in a science or engineering related field

Aseptic processing

Protocol generation

Sterilization

Validation

FDA/USDA