Associate General Manager Project And 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 equipments 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.

Qualifications

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