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¤ý Responsible for developing designs for complete and complex engineering systems, structures and plant arrangements.
¤ý Work closely with clients (internal and external) and colleagues ? a friendly, collaborative attitude is essential
¤ý Develop engineering drawings (eg. P&IDs, PFDs, GAs, line diagrams, etc.) and 3-D piping and equipment design using AutoCAD, Inventer, Solidworks, etc. and current sanitary design requirements as per ASME BPE.
¤ý Write, review and defend technical documents such as CQV test protocols (IQ/OQ/PQ), SOPs, deviation reports, tech memos, etc;
¤ý Critique and evaluate engineering documents such as technical specs, equipment/component/instrument data sheets, P&IDs, piping isometrics, GA drawings, sizing calculations, functional specifications, etc;
¤ý Perform activities like FAT/SAT and Installation verification for new equipment and also for modifications to existing equipment
¤ý Draft and execute commissioning protocols related to production equipment
¤ý Use Microsoft Project, Primavera to prepare overall baseline schedules comprising various phases i.e. Pre-concept/Concept Design; Basic Design; Detailed Design; Construction & Commissioning; Qualification
¤ý Coordinate with the various project leads and stakeholders so as to take a proactive approach in driving projects
¤ý Track and monitor projects as per baseline project budgets, highlighting variances.
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¤ýEngineering (mechanical, chemical or biotech) background
¤ý +5 years working experience in biopharma, food or chemical industry
¤ý Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP)
¤ýExperienced user of CAD programs
¤ý Design experience with sanitary, food-grade facilities (3A, ASME BPE, etc.)
¤ý A good understanding of design principles and standards within the biopharmaceutical facilities.
¤ý Process and equipment knowledge of biological drug substance manufacturing processes
¤ý Knowledge of Costing and Scheduling of capital projects
¤ý In-depth knowledge of Microsoft Project
¤ý Experience in working with/coordinating EPCM contractors
¤ý Experience in working with Owner Engineering organization
¤ý Experience in mid/large sized facility construction projects and familiar with the various project stages i.e. feasibility, concept design, basic, detailed engineering, construction, pre-commissioning, CQV including IOQ related activities
¤ýExcellent oral and written communication skills in English
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