담당업무
ㆍ Responsible for developing designs for complete and complex engineering systems, structures and plant arrangements.
ㆍ Work closely with clients (internal and external) and colleagues ? a friendly, collaborative attitude is essential
ㆍ 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.
ㆍ Write, review and defend technical documents such as CQV test protocols (IQ/OQ/PQ), SOPs, deviation reports, tech memos, etc;
ㆍ 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;
ㆍ Perform activities like FAT/SAT and Installation verification for new equipment and also for modifications to existing equipment
ㆍ Draft and execute commissioning protocols related to production equipment
ㆍ 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
ㆍ Coordinate with the various project leads and stakeholders so as to take a proactive approach in driving projects
ㆍ Track and monitor projects as per baseline project budgets, highlighting variances.
자격요건
ㆍEngineering (mechanical, chemical or biotech) background
ㆍ +5 years working experience in biopharma, food or chemical industry
ㆍ Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP)
ㆍExperienced user of CAD programs
ㆍ Design experience with sanitary, food-grade facilities (3A, ASME BPE, etc.)
ㆍ A good understanding of design principles and standards within the biopharmaceutical facilities.
ㆍ Process and equipment knowledge of biological drug substance manufacturing processes
ㆍ Knowledge of Costing and Scheduling of capital projects
ㆍ In-depth knowledge of Microsoft Project
ㆍ Experience in working with/coordinating EPCM contractors
ㆍ Experience in working with Owner Engineering organization
ㆍ 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
ㆍExcellent oral and written communication skills in English
우대사항
ㆍ해외근무 가능자
ㆍ영어가능자
ㆍ전공 : 바이오·유전공학, 화학공학