Asst/DM Manager – Process & Regulatory

10 years

0 Lacs

Posted:3 weeks ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Preparation of PFD, URS, FDS, Cycle Time Analysis etc.
  • Calculation for Utilities, Peak Loads, Pipe/Pump sizing, Equipment capacity, and other accessories capacity/load/size
  • Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents (VMP, FAT, IQ, OQ, PQ etc)
  • Equipment/Instrument Selection, Vendor Evaluation, Techno-commercial Report Preparation
  • Site execution of validation activities

Desired Skills

Basic Requirements:
  • Knowledge of chemical engineering unit operations/processes
  • Knowledge of chemical engineering design calculations
  • Knowledge of Biotech & Pharmaceutical Processing
  • Knowledge of AutoCAD / AutoCAD Plant 3D /REVIT
  • Knowledge of various Regulatory / GMP / Statutory requirements related to Pharmaceuticals & Biotech manufacturing (Preferred)
  • Knowledge of engineering guidelines like ISPE, ASME, ASME-BPE, ASTM etc
Skills:
  • Hands on experience in Basic and Detailed Engineering for Pharmaceutical & Biotech facility
  • Experience in Preparation Heat & Mass Balance calculation, PFD & P&ID.
  • Experience in sizing of equipment’s/ Preparation of data sheet for all equipment’s such as Reactors, condenser, columns pumps, agitators, tanks, scrubber etc.
  • Provide Process data for all instruments and interlocking descriptions.
  • Preparation of Hydraulic calculation for pumps, pipeline.
  • Carrying out Hazop study.
  • Calculation of Clean and general utility consumptions.
  • Lead the engineering team with respect to process requirement.
  • Co-ordination with other departments (3D Mechanical, HVAC, Civil, Electrical)
  • Preparation of Technical bid evaluation.

Qualification

  • BE-Chemical Engineering / Biochemical Engineering / Biotechnology
  • M.Pharma/B.Pharm M.Sc / B.Sc. (Chemistry/ Biochemistry/ Biotechnology)

Relevant Experience

  • 10 to 12+ Years of relevant experience in Pharmaceutical/Biotech projects
  • Experience from Consulting & Engineering (Pharmaceuticals) Companies- Preferred
  • Experience from Finished Pharmaceuticals (Biotech, Injectable plant)- Preferred
  • Experience from Equipment Manufacturing Companies- Preferred

Location

Thane

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