LeadSpecialistSME - Clean Utility

Job Role: Lead/Specialist/SME Clean Utility

Required Experience: 15 years

Job Description:

As a SME/Specialist in Clean Utility Generation & Distribution design

• Experience in Pharma Biotech High purity water industry is a must.
• Coordination with other disciplines & conducting design review for engineering activities.
• Have experience in the perform the Gemba for the clean & black utility generation & distribution.
• Prepare URS for clean utility skids/equipment & Distribution package (Purified Water Portable water Water for Injection Pure Steam & Process gases). Black utility is an added advantage.
• Estimation of Utility Equipment Generation Capacities for clean utilities. Black utility is an added advantage.
• Have good Knowledge in technical selection of components/devices and equipment and preparation of their technical specifications for both clean & black utility.
• Have good knowledge in the pipe sizing and hydraulic calculation pump sizing tank sizing Pump pressure drop calculation clean utility loop design calculation and sizing review of clean utility piping isometrics layout P&ID vendor drawings Mass & Energy Balance .Black utility is an added advantage.
• Prepare Evaluate & Finalize the tender for the utility packages.
• Have experience in qualification of the vendor and Equipment (validation life cycle)
• Have experience in Planning & Estimation of the project deliverables in the different phase of project
• Have updated knowledge in cGXP and in regulations and guidelines ISPE EudraLex USP ASME WHO EN PDA Safety (not limited to)
• Have good knowledge in Contamination control Strategy.

Preferred Competencies

• Are determined and have a solid customer understanding and a consultative mindset
• have an interest in following the technological developments and trends in the field.
• are eager project member and are excited for solving complex tasks
• Able to collaborate and work with cross disciplinary
• Understanding of your colleagues’ personal and cultural differences
• Fluent in English spoken and written

Education and Work Experience

• BE / B. Tech or M.Sc. / ME / M. Tech in Mechanical or equivalent with minimum and relevant experience of 15years.
• Experience in CD BD DD & Construction Phases of project execution.
• Good knowledge of the current relevant Engineering & Pharma legislation/guidelines/standards
• Knowledge/ work experience in MS VISIO AUTO CAD NAVISWORK are preferred.