• Responsible to execute and do the formulation & Filling batch manufacturing activities.
• Responsible to operate and to execute to operate the single use mixer & controllers, and other applicable equipment’s in Formualtion-1 & Formualtion-2 area.
• Responsible to execute and do the component preparation activities.
• Responsible to operate and to execute the Autoclave, Part washer and other related equipment in component wash area.
• Responsible to execute Vial & PFS filling activities.
• To follow Safety guidelines and Safety policies are of sterile operations in projects and operations. 
• To follow QMS-Validation-cGMP Compliance in sterile manufacturing facilities.
• To provide the assistance to FFM-2 personnel to maintain all time cGMP readiness in the plant and support the various audits.
• To prepare and to execute the FFM-2 personnel for preparation of SOP (Standard operational procedure), Protocols, Reports, both paper and MES (Manufacturing execution system), and other GMP documents related to sterile operations.
• To be available in shifts to support for the planned activity/batches execution
• Responsible for Filter integrity machine execution
• Preparation of SOP, Study protocols, Study reports and other GMP documents related to sterile operations and C&Q.

**Required Qualifications:**

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biotechnology, or related scientific discipline
• Minimum 5+ years of hands-on experience in pharmaceutical or biopharmaceutical manufacturing environments
• Demonstrated expertise in sterile manufacturing operations and aseptic processing techniques
• Comprehensive knowledge of current Good Manufacturing Practice (cGMP) and Quality Management System (QMS) requirements
• Proven experience operating and maintaining single-use mixers, controllers, autoclaves, and component washing equipment
• Proficiency in vial and pre-filled syringe (PFS) filling operations
• Experience with Manufacturing Execution Systems (MES) and GMP documentation
• Strong understanding of filter integrity testing and validation protocols
• Ability to prepare and execute Standard Operating Procedures (SOPs), study protocols, and technical reports
• Excellent knowledge of pharmaceutical safety guidelines and sterile operation protocols
• Ability to work rotating shifts and flexible schedules as required for batch execution

**Preferred Qualifications:**

• Advanced degree (Master's) in Pharmaceutical Sciences, Chemistry, or related field
• Experience with validation and qualification (C&Q) activities in regulated environments
• Familiarity with FDA or international regulatory compliance standards
• Previous experience supporting internal and external audits in GMP facilities
• Knowledge of equipment troubleshooting and preventive maintenance
• Experience mentoring and training production personnel
• Certification in pharmaceutical manufacturing or quality systems