About this role
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)