Main Roles & Responsibilities
As a SME/Specialist in Clean Utility Generation & Distribution design, you’ll:
· Have good communication skill.
· 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
We care about who you are as a person. In the end, how you work, and your energy is what impacts the effort we do as a team. As a person, you:
· 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
In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this role:
· BE / B. Tech or M.Sc. / ME / M. Tech in Mechanical or equivalent, with minimum and relevant experience of 15+years.
· 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.
