Associate General Manager, Project & Engineering

We are looking for Process Equipment Lead with B. E/ B. Tech Degree with 15- 20 Years of experience for our Biosimilar R&D facility Based out of Ahmedabad. Below are the further details.

Experience 15 - 20 Years

Education: B.E/ B. Tech (Mechanical/ Electrical/ Electronics/ Instrumentation)

Roles & Responsibilities

• Responsible for the Plant Maintenance activity of DS (Drug Substance) section equipment's such as Fermenters, Process vessels, CIP vessels, batch centrifuges, TFF systems, Merck chromatography columns, Filter press.
• Responsible for Maintaining of biologics MFG units (Cell Culture), Filling Facility (DP),Quality Control, Warehouse and R&D facility .
• Maintenance of Biologics manufacturing facility (Mammalian) including Development and QC lab(Microbiology).
• Responsible for QMS Documentation validation and new Equipment Qualification.

Required Instruments Exposure :

• Bioreactor
• Fermenter
• Media, Buffer & CIP vessel
• Continuous Centrifuge
• Continues Kill system
• Homogenizer
• Chrome system
• TFF system
• Autoclave
• Chromatography

Candidate Details:

• The candidate should be from Biopharma industry having exposure Drug Substance and Drug product Maintenance.
• The candidate should have exposure to regulatory Audits.
• The candidate should be aware of GDP/ GMP Process.
• The candidate should have exposure to new equipment qualification & QMS as well.
• The candidate should have good communication skills.

Education: B.E/ B. Tech (Mechanical/ Electrical/ Electronics/ Instrumentation)