Executive - BBM

Enzene Biosciences Ltd.; Pune District; Presencial; INR 500.000 - 800.000; Jornada completa

Descripción de la vacante

Enzene Biosciences Ltd. Pune is seeking a hands-on bioprocess technician to execute upstream manufacturing batch activities and operate equipment like fermenters, centrifuges, homogenizers, mixers and autoclaves.

You will maintain batch records, ensure cGMP compliance and safety, and collaborate with cross-functional teams to optimize production processes. Experience with E. coli-based biopharmaceutical production and equipment qualification is preferred.

Formación

• Working in a cGMP environment.
• Experience in e.coli based biopharmaceutical production processes
• Capability to work in a team and ability to handle demonstrate a good team spirit
• Strong interpersonal skills are required with the ability to work cross-functionally with internal and external customers

Responsabilidades

• Execute and operate upstream manufacturing batch activities
• Operate process equipment like fermenter, centrifuge, homogenizer, mixers, autoclave, etc.
• Manage vial thaw, cell counting and other seed expansion activities
• Manage media preparation and filtration activities
• Maintaining Quality Management Systems related documentation like - deviations, change controls, risk assessment documents etc.
• Monitoring of batch performance and data
• Hands-on experience with SS fermenters
• Experience in the equipment qualification and validations
• Proper documentation of batches as per SOP and written procedures
• Follow environment, health, and safety (EHS) requirements in the workplace

Conocimientos

cGMP environment

ecoli biopharma production

team collaboration

interpersonal skills cross-functional

Descripción del empleo

1. Technical Responsibilities

• 1.1 Execute and operate upstream manufacturing batch activities
• 1.2 Operate process equipment like fermenter, centrifuge, homogenizer, mixers, autoclave, etc.
• 1.3 Manage vial thaw, cell counting and other seed expansion activities
• 1.4 Manage media preparation and filtration activities
• 1.5 Maintaining Quality Management Systems related documentation like - deviations, change controls, risk assessment documents etc.
• 1.6 Monitoring of batch performance and data
• 1.7 Hands-on experience with SS fermenters
• 1.8 Experience in the equipment qualification and validations
• 1.9 Proper documentation of batches as per SOP and written procedures

2.0 GMP compliance

• 2.1 Apply Good Manufacturing Principles in all areas of responsibility
• 2.2 Follow environment, health, and safety (EHS) requirements in the workplace
• 2.3 Ensuring compliance to cGMP in area as defined by SOPs

3.0 Skills Required

• 3.1 Working in a cGMP environment.
• 3.2 Experience in e.coli based biopharmaceutical production processes
• 3.3 Capability to work in a team and ability to handle demonstrate a good team spirit
• 3.4 Strong interpersonal skills are required with the ability to work cross-functionally with internal and external customers