We’re Hiring | For R&D Upstream Process.
- 📍 Location: Biological E Limited, Shamirpet, Hyderabad
- 🎓 Qualification: M. Sc / B. Tech (Biotechnology) with 3-5 years’ experience
* Preparation of User Requirement Specifications (URS) for new equipment and systems. Involvement in vendor selection, technical evaluation, and procurement activities in coordination with purchase and engineering teams.
* Preparation, and participation in installation, commissioning, qualification (FAT & SAT) activities of equipment, Facility as per approved protocols and timelines.
and support of qualification protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
* Ensuring equipment qualification activities are performed in compliance with approved SOPs and regulatory guidelines and review of qualification documents, reports, and test results for completeness and accuracy.
* Identification and reporting of deviations during qualification/validation activities and support in investigation and closure. Coordination with cross-functional teams (QA, QC, Engineering, Validation) for timely completion of qualification activities.
* Ensuring calibration status of instruments and equipment before execution of qualification activities. Maintaining proper documentation and traceability of all qualification and validation records.
* Ensuring readiness of equipment for routine operation post qualification and handover from project/validation team and handling of different capacities of fermenters from small scale to pilot scale.
* Preparation of inoculum, medium for the reactor. Strict adherence to instructions and written procedure for execution of activities.
* Able to handle different instruments like shaker incubator, Bio-safety cabinet, centrifuge, spectrophotometer, microscope & LAFU.
* Monitoring and ensuring compliance with GMP, EHS, and company policies during all qualification and validation activities.
If you’re passionate about R&D Upstream Process, apply or share your CV with Kusum.Emandi@biologicale.com.
ABAC
