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Validation Engineer

Posted on 1/9/2019

Position Summary

 

Review qualification requirements for any new instrument and process with system owner and cross-functional team.  Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), engineering, process and cleaning validations.  Execute protocols and related activities associated with validating equipment, systems utilities, processes, transferring new products/processes from R&D to manufacturing and executing processes/documentation improvements.  Preparation, execution, and review of laboratory equipment validations.  Initiate and investigate protocol deviations and coordinate follow up with QA.  Coordinate with a cross-functional team for internal and external audits.  

 

Requirements

 

Batchelor's Decree in Microbiology or equivalent. 

Knowledge of cGMPs

Knowledge of Validation Guidelines - SOPs, FDA, ICH, EU, MHRA, OSHA, DEA, and MSDS guidelines and requirements

Interpret and develop documents such as Site Master Plans, Validation Master Plans, Validation Protocols, Technology Transfer Documents, Master Production Records, Operating and Maintenance Instructions. and Procedures Manuals.

 

Job Location:

 

103 Beaver Court

Cockeysville, MD 21030

 

Resumes to:

 

Pharmaceutics International, Inc.

Attn:  T. Kane

10819 Gilroy Road

Hunt Valley, MD 21031