Validation Engineer

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