Company: Pharmaceutics International Inc
Posted on: January 15, 2019
Validation Engineer- 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, 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 cross-functional team for internal and external audits. Bachelors Degree 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.
Keywords: Pharmaceutics International Inc, Baltimore , Validation Engineer, Engineering , Baltimore, Maryland
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