Job Description

• Preparation and execution of process, area and equipment qualification / validation protocols.
• Preparation of various reports like process, equipment, area qualification and validation.
• Preparation and Review of BPR.
• Request and Issuance of BPR.
• Preparation and execution of study protocols, preparation of study and technical reports.
• Readiness of downstream area and other areas like corridors and washing area etc. for manufacturing operations.
• Handling of SAP related activities like process and maintenance.
• Operating downstream equipment's for process and CIP/SIP.
• E.g. TFF system, buffer and refolding vessels, AKTA Pilot system, k-prime system, pH & Conductivity meter, Autoclave, DHS etc.
• Clean and monitor the LAFU's, Pass boxes, Biosafety cabinets, CLAFU etc. Execution of production batches in the downstream process area as per approved BPR and submission of the same to QA.
• Testing of in-process samples like measurement of OD, pH, conductivity etc.
• To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site.

Work Experience
1 to 4 years
Education
Post Graduation in Biotechnology or Biochemistry
B.Tech in Biotechnology or Biochemistry
Competencies

Skills Required