Validation EngineerPharmaceutics International Inc
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. Bachelor’s 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.
We are an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of race, color, national origin, religion, gender, age, veteran status, political affiliation, sexual orientation, marital status or disability (in compliance with the Americans with Disabilities Act) with respect to employment opportunities.