Scale-up Executive, Bioreactor Operations

Job highlights

• The candidate must demonstrate a strong quality mindset,documentation discipline,safety awareness,and ability to work independently during rotational / night shifts
• Ensure effective shift handover and maintain continuity of critical manufacturing operations.
• Operate bioreactors / fermenters and associated upstream processing equipment as per approved SOPs and batch records.

Raspa is a biopharmaceutical company that is committed to reducing the cost of treatment for patients with cancer and other severe diseases. Our diverse and inclusive team is amalgamating technological innovation and automation strategies to make healthcare more accessible, affordable, and sustainable. We are seeking a Scale Up Executive (Bioreactor Operator) responsible for the safe, compliant, and efficient execution of upstream bioprocessing and bioreactor operations in R&D and pilot scale facility. The role requires hands-on capability in bioreactor operation, aseptic processing, process monitoring, sampling, equipment preparation, and documentation. The candidate must demonstrate a strong quality mindset, documentation discipline, safety awareness, and ability to work independently during rotational/night shifts.

You will:

• Operate bioreactors/fermenters and associated upstream processing equipment as per approved SOPs and batch records
• Execute media preparation, equipment preparation, sterilization/SIP, inoculation, feeding, process monitoring, sampling, and harvesting activities as applicable
• Monitor critical process parameters including pH, DO, temperature, agitation/RPM, airflow, pressure, feed rate, and volume/weight
• Perform aseptic operations including sterile sampling, aseptic connections, transfers, and additions
• Follow cleanroom/gowning, sanitization, contamination-control, and aseptic practices
• Complete batch records, equipment logbooks, checklists, forms, and electronic records accurately and contemporaneously
• Strictly follow GDP, ALCOA+, data-integrity, SOP, and safety requirements
• Identify and immediately escalate process deviations, equipment abnormalities, documentation errors, contamination risks, and safety incidents
• Support deviation investigations, CAPA, change controls, audits, and inspection readiness
• Perform equipment cleaning, sanitization, line clearance, and pre-use checks
• Ensure effective shift handover and maintain continuity of critical manufacturing operations
• Contribute to continuous improvement, 5S, safety, and operational excellence initiatives

Our ideal candidate will have:

• B.Tech/M.Sc in Biotechnology, Bioprocess Engineering, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or relevant field
• 0-2 years: Freshers or candidates with relevant internship/industrial exposure may be considered for the position
• Excellent documentation and record-keeping practices
• Ability to monitor and respond to process abnormalities
• Basic troubleshooting and process understanding
• Strong attention to detail and "Right First Time" mindset
• Good communication and shift-handover skills
• High level of ownership, integrity, and accountability
• Ability to work effectively in a regulated manufacturing environment
• Must be willing to work rotational shifts, including night shifts
• Ability to safely lift and handle materials/equipment up to 20 kg, in accordance with site safety procedures

Nice to have:

• Experience with commercial/pilot-scale bioreactors, seed trains, CIP/SIP, SCADA/DCS/PLC systems, MES/e-BMR, and electronic documentation systems will be an advantage
• Practical understanding of bioreactor/fermenter operations
• Knowledge of aseptic processing and contamination control
• Strong understanding of GMP, GDP, ALCOA+ and data integrity

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.