Senior Executive – Production Mammalian
Lupin · Pune/Pimpri-Chinchwad Area
- Experience7–8 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelexecutive
- Posted21 Sept 2026
About Lupin
Lupin is hiring in Pune/Pimpri-Chinchwad Area in pharma biotech. This role looks for around 7+ years of experience.
Skills
- cell culture operations
- bioreactor operations
- GMP documentation
- GMP validation
- process validation
- technology transfer
- process scale-up
- media preparation
- cell banking
- CIP
- SIP
- process characterization
- deviation investigation
- audit preparation
The role
A process engineer at a pharmaceutical biotechnology manufacturer executes mammalian cell culture, bioreactor operations, and GMP validation, while supporting technology transfer and process scale-up. The role applies cell culture operations and GMP documentation to maintain compliant manufacturing processes.
Full job description
Job Description
Responsible for manufacturing operations related to upstream of Mammalian Manufacturing facility.
Preparation and review of GMP documents like SOPs, BPRs, qualification and validation protocols, technology transfer documents and other process or facility related documents for media preparation and cell culture operations. Execution of disposable bioreactor, SS bioreactor and glass bioreactor operations as per written procedure. Execution of media fill, inoculum transfer and subculture operations as per written procedure. Responsible for execution of media preparation, CIP and SIP of bioreactors, cell culture and cell banking operations as per written procedures. In-process recording of process parameters and In-process sample analysis for media preparation and cell culture operations. Maintenance of facility and equipment related to media preparation operations, cell culture operations and cell banking operations. Co-ordinate with QC, QA, Engineering, WH, MSAT and R & D departments. Execution of qualification activities related to equipment and process. Preparation of documents related to tech transfer and scale up of process. Participate in tech transfer and scale up of process. Preparation, execution & maintenance of SOPs, BPRs, qualification documents and other facility related documents i.e. URS. Plan and execute operations related to process characterization & process validation. Review of executed BPRs and protocols. Planning and facing of internal as well as external audits/visits as per business requirement. Deviation identification and investigation assistance for the facility related deviations.
Work Experience
7-8 years
Education
Post Graduation
Graduation in Biotechnology or Life Science
Competencies