Process Engineer Job in Aditi Consulting

Job Description Support engineering activities. Development and/or maintenance of deliverable tracking and project schedule Equipment and process change control authoring and management, as needed Authoring and management of engineering, operational, and validation life cycle documents such as user requirement specifications, criticality assessments, drawings, commissioning test plans and summary reports, asset information sheets, maintenance/calibration plans, spare part plans, operating procedures, and safety documentation, as needed Coordination and execution of engineering testing and training activities with end users, as needed Coordination of validation IQOQPQ activities, as needed Validation/qualification testing, documentation authoring, or execution, as needed Management of project closeout and file transfer activities. Responsible for: Validation and qualification activities to support the qualification of Eight single-use bioreactors, Two chromatography skids, Two single-use mixers, Other miscellaneous equipment. Validation/Process Engineer Has advanced knowledge of the principles, theories and concepts applicable to a wide range of work in a discipline and broad knowledge of principles and concepts in other disciplines Applies technical and functional knowledge to assist in experiment/project design that will enable project team to meet goals Works independently on a broad range of difficult problems Suggests new, innovative solutions to problems. TYPICAL MINIMUM EDUCATION AND/OR EXPERIENCE: Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline 3+ years of Process/Project Engineering related experience 2+ years in a regulated industry (Drug Substance preferred) Access to Maximo, Trackwise, and EDMS/MES preferred Must be able to read and understand English-written job instructions and safety requirements.