Job Title: Validation Engineer I/ II Location: Athens, GA Type: Contract 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
Skills:
Aseptic processing
Protocol generation
Sterilization
Validation
FDA/USDA
Required:
HVAC
VALIDATION ENGINEER
CGMP
FILLING LINES
BIOPHARMACEUTICAL
Education:
Bachelors , preferable in a science or engineering related field
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Full-time