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Job ProfileSenior / AM / DM – Process & Regulatory
Date of Entry12-Oct-2022
No of Openings1
Job Location(Mumbai/Hyderabad)
Preferred Candidate Location
QualificationB Tech/ BE- Biotech or Bio Chemical or Chemical Engineering / Bio Process Engineering (8 – 10 Years experience) or M Tech in biotech / M Sc in biotech.
Total Experience8 – 10 years
Age Criteria
Salary Range15 LPA
Job SpecificationBasic requirement:
1)Knowledge of Biotech engineering / Bio chemical unit operations/ Bio processes
2)Knowledge of Biological plant design
3) knowledge of AutoCAD (Not compulsory )
4)Knowledge of various Regulatory / GMP / Statutory requirements related to
Biotech manufacturing (Preferred)
5)Knowledge of engineering guidelines like ISPE, ASME, ASME-BPE, ASTM etc
Roles & Responsibilities1) Preparation of PFD, Mass Balance, URS, FDS, Cycle Time Analysis etc.
2)Calculation for Utilities, Peak Loads, Pipe/Pump sizing, Equipment capacity, and other accessories capacity/load/size
3) Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents (VMP, FAT, IQ, OQ, PQ etc)
4)Equipment Size & Selection, Vendor Evaluation, Techno-commercial Report Preparation
5) Site execution of validation activities
6) Pressure drop calculation for utility systems (Liquid and Gases) with PIPE- FLO® Software.
7) Preparation of proposals for Basic and Detailed design.
8) Review of 3D models and guidance to designer for modeling.
9) Preparation of P&ID and data sheets.
10)Development of P&ID and PFD. Design of process equipment’s like fermenters, process equipment, CIP systems etc.
11)Development of CIP strategies and automation philosophies.
12) Process scheduling with schedule pro and mapping of resources (water, steam, air, power, CHW and CTW, man power etc) and analysis of results for design of utility systems.
13) Mass and heat load calculation of design of utility systems, 3D piping review.
14) Review of RA, URS, Data sheets, FAT, SAT and commissioning & qualification documents.