Process/ Project Engineer
Responsibilities:
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Experience in upstream / downstream / Central services process operation, (experience in equipment design for process equipment will be an advantage).
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Responsible for basic and detailed design, commissioning and qualification activities, including URS development, FAT, SAT, DQ, IQ, OQ and PQ.
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Review industry practices for best-in-class approach.
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Ensure that the appropriate Quality standards are applied consistent with best practice and internal Quality Standards and expectations.
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Engage with project teams to deliver the project from conceptual through implementation phase, encompassing support for a wide range of engineering and construction requirements.
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Coordinates with different functions like manufacturing, project engineering team, validation and quality for implementation of changes associated with the project.
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Work independently and/or with the project manager to complete the engineering projects within schedule, budget and quality constraints.
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Any other task as assigned by Supervisor/Manager.
About You:
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Diploma/Degree in Chemical Engineering, Chemistry or equivalent with at least 5 years' experience in a process engineering role or similar role with a biologics manufacturing plan
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At least 2-5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in Process Engineer
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In Biologics industry with understanding of cGMP requirement
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Should have Design experience at various stages of project (Base, Detailed design)
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Preferably handling the Autoclave, Glove box, CIP Skid during project phase
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Able to support Installation, Commissioning & Qualification activity at site.
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Any other task given related to Process.