Validation Engineer Piney Technical Services Athens, GA Job Details Full-time 12 hours ago Qualifications Requirements specification Requirements design Preventive action implementation Regulatory compliance Strategy Development (Quality assurance practices) Production deviation management Quality control preventive actions Corrective and preventive actions (CAPA) Mid-level Technical support Quality reports Production validation processes Bachelor's degree Change management for system development Continuous improvement Technology transfer (scale-up process) Quality inspection Compliance support tasks Commercial freezers Collaboration with manufacturing teams Laboratory freezers Technical skills instruction Sterile products production Cleaning and sanitation quality assurance Test Planning (Quality assurance practices) FDA regulations Audit support Air conditioning Engineering manufacturing support Full Job Description Independent drafting and execution of complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment. Candidate is considered and experienced professional requiring minimal assistance from more experienced colleagues. The candidate is balancing their own competing priorities while helping ensure that work generated globally is conducted per regulatory requirements and company procedures. Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement. Train personnel in quality and validation principals Support, Engineering and 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. 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

Skills:

Aseptic processing Protocol generation Sterilization Validation

FDA/USDA

Education:

Bachelors , preferable in a science or engineering related field