Sr. Engineer-Process And Equipment's Lotus Group

About Lotus Group

Job Description

To review the process flow as per the customers requirement. To develop process flow for all pharmaceutical formulations. To create capacity and cycle time analysis with the help of the project manager and define equipment sizing. To create technical specifications (TS) and data sheets for production, packaging, and process equipment. To float inquiries to vendors to get offers for production, packaging, and process equipment. To solve the technical queries of vendors in coordination with the project manager or the client to get correct technical offers. To follow up with the vendors for their offers or quotes. To make a comparative statement of the offer (technical and commercial). Troubleshoot the same with the vendor to get at- par basic data and requirements. To organize meetings with the vendors. To create make / vendor list of all production machinery as per the project budget. To get involved in vendor meetings and finalize the equipment on the technical front as per TS requirements. To provide the relevant technical details for the preparation of a purchase order (PO) based on the decision from the client or project or purchase team for the procurement of equipment. To start coordinating with the vendor for the release of Factory Acceptance Test (FAT), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols and working files after the PO is released. To ensure that all steps of documentation are followed and correct approvals and signatures are availed for future use of the document. To give the necessary protocols to the testing engineer and get the completed report from the same, respectively, during each testing and qualification activity. To check and verify all documents for missing certificates or documents as per requirements and get it coordinated and completed with the vendors. To prepare the final documentation for submission and further checking from the validation department. To coordinate with site engineers on probable issues faced during testing and commissioning of the equipment and get it resolved with the respective vendors. Requirements Skills & Knowledge: Must have knowledge of pharmaceuticals formulation processes and equipment used in the system. Must have detailed knowledge of the pharmaceutical industry in general, dosage forms in the formulation industry, and various equipment and systems that go into the operation and construction of a facility. Must be fluent in both written and spoken English. Should be a self-starter and motivated to achieve goals and targets. Should be able to draft templates and documents as per standard requirements. Preferred Should have adequate knowledge of the latest Food and Drug Administrations (FDA) requirements on documentation for equipments. Should have good knowledge of qualification and validation documentation for pharma processes, packaging, and production equipment. Should be able to draft technical specifications independently with minimum guidance. Attending practical validation or working on the production floor would be an added advantage. Benefits Gratuity Benefit: Provided in accordance with applicable laws. Personal Accident Policy: Coverage starts from the date of joining the employment. Mediclaim Policy: Comprehensive health insurance coverage on confirmation of employment.,