Senior Engineer

2 weeks ago

Chennai, India Wood Full time
Process Engineer should be able to understand the sequence of finalizing each of the process documents.
Should be able to understand the project requirements (API / Biotech and Formulations) / philosophies and carryout process activities independently.
Should have knowledge in Concept / Basic / Detailed Engineering of Life Sciences Projects
Process inputs for preparation of Mechanical Data sheets. Understands multiple Process Engineering drawings/documents such as Raw materials & utility consumption calculations, Design Basis, Piping Material Specifications (PMS), all List Items, Line List, Valve List, Equipment List, Motor Drives List, Vendor Package PIDs, Equipment Process Data sheets, Noise data sheets, 3-D Model review etc.
Should have knowledge in good engineering practices and general industry standards such as ASME BPE, ISPE Baseline Guides and ISPE Good Practice Guides.
Must be familiar of cGMP, Schedule M (India), 21 CFR 210 & 211 (US), EudraLex Volume 4 (EU), ICH, USP and WHO guidelines.
Should be conversant with sequential activities, cycle time for schedule management towards deliverables to control activities and closeouts in an appropriate manner.
Coordinate with drafting team and engineering team for process inputs and drawing preparation.
Work closely with Project team as point of contact for internal / external clients, including understanding their requirements and meeting project expectations.
Implement quality assurance processes as defined in project quality plan and overall organisational requirements.
Should have thorough understanding of project interfaces and discipline interdependencies for performing process engineering activities on an assigned project.
Implement risk assessment, and mitigation strategies related to process to ensure project success.

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