Principal Commissioning/Validation Engineer I

We are looking for Principal Commissioning/Validation Engineer I for our client in Athens, GA

Job Title: Principal Commissioning/Validation Engineer I

Job Location: Athens, GA

Job Type: Contract

Job Overview:

Pay Range: $23.81hr - $28.81hr

Requirement/Must Have:

• Experience with Ellabs data loggers and software.
• Understanding of cleaning validation concepts and principles.
• Understanding of pharma grade utilities including water, HVAC, and gases.
• Knowledge of Aseptic processing.
• Experience in Protocol generation.
• Knowledge of Sterilization and Validation.
• Familiarity with FDA/USDA regulations.
• Bachelors degree, preferably in a science or engineering-related field.

Responsibilities:

• Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME.
• Perform requalification and periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas.
• Write and execute protocols and complete final reports.
• Support Maintenance, Engineering, and Production Departments 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.
• Develop and assist with audit responses and completion of assigned CAPAs by target due dates.
• Ensure Validation areas are inspection ready at all times.
• Support Change Control, Deviation, and CAPA activities.

Skills:

• HVAC.
• Validation Engineer.
• CGMP.
• Filling Lines.
• Biopharmaceutical.
• Aseptic processing.
• Protocol generation.
• Sterilization.
• Validation.
• FDA/USDA.

Qualification And Education:

• Bachelors, preferably in a science or engineering-related field.

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities