Biotechnologist Officer

Job Description
POSITION: BIO-PROCESS OFFICER
Executive Position Summary
The Bio-Process Officer is responsible for executing fermentation and upstream production activities, monitoring process parameters, maintaining GMP compliance, completing production documentation, and supporting safe, efficient batch manufacturing under the guidance of the Bio-Process Shift Incharge.
Key Qualifications & Attributes

• Experience Range: 2 to 5 years of hands-on experience in industrial fermentation, bio-pesticides, probiotics, enzymes, APIs, or related biologics sectors.
• Technical Mastery: Working knowledge of upstream processing equipment, automated CIP/SIP loops, and SCADA/PLC software platforms.
• Analytical Aptitude: Demonstrated capacity to interpret real-time process charts, diagnose parameter trends, and conduct baseline troubleshooting.
• Interpersonal Alignment: Proven capability to collaborate seamlessly across cross-functional matrix units, including Quality Assurance (QA), Quality Control (QC), Engineering, Utilities, and Warehouse management.

Core Job Responsibilities
ActivityResponsibilitiesShift Preparation

• Conduct a comprehensive shift handover review, analyzing logbooks, active batch parameters, and ongoing deviations.
• Verify the operational readiness of critical utilities (chilled water, steam, compressed air, process water).
• Enforce 100% compliance with Personal Protective Equipment (PPE) and cleanroom gowning protocols before shop-floor entry.
• Audit the physical status, cleanliness, and housekeeping (5S) of the assigned production block.

Raw Material Verification

• Verify issued raw materials against the Batch Manufacturing Record (BMR) for quantity, material codes, and lot numbers.
• Inspect material labels and review Certificates of Analysis (COA) to ensure raw material integrity.
• Enforce First-In, First-Out (FIFO) and First-Expired, First-Out (FEFO) inventory management principles.
• Supervise and execute accurate material dispensing, cross-checking weights, and authenticating dispensing records.

Media Preparation

• Execute precise media preparation sequences strictly adhering to the validated master formulas.
• Monitor, adjust, and record critical intermediate attributes, including media pH and temperature profiles.
• Oversee and execute the aseptic transfer of media to preparation vessels or fermenters, minimizing bio-burden risks.

Fermentation Operations

• Monitor and control real-time process parameters via SCADA/PLC interfaces, including:
• pH and Dissolved Oxygen (DO) levels.
• Temperature, Agitation Speed (RPM), and Airflow rates (vvm).
• Vessel pressure, foam levels, and automated nutrient feeding rates.
• Execute precise tracking of exponential growth phases, managing feed-line additions safely.
• Perform real-time troubleshooting of minor process anomalies and escalate major deviations immediately.

CIP/SIP

• Program, execute, and monitor automated Clean-In-Place (CIP) and Sterilization-In-Place (SIP) cycles for fermenters and transfer lines.
• Verify critical sterilization hold parameters (121 C} at designated pressure and time duration).
• Maintain exact documentation of cleaning validation, chemical concentrations, and rinse-water conductivity tests.

Sampling

• Collect in-process batch samples from fermenters at predefined intervals utilizing strict aseptic sampling techniques.
• Label, document, and securely transfer samples to Quality Control (QC) and Microbiology laboratories for analysis.
• Review quick-test physical analytics (e.g., optical density, microscopic purity) to confirm batch health

Documentation

• Maintain real-time, concurrent entries in Batch Manufacturing Records (BMR) following Good Documentation Practices (GDP).
• Complete equipment logbooks, shift logs, utility utilization reports, and material reconciliation sheets accurately.
• Ensure all data entry fields are validated, signed, and countersigned as required by regulatory standards.

Equipment Monitoring

• Conduct routine physical inspections of fermenters, transfer pumps, valves, instrumentation probes, and gaskets.
• Monitor auxiliary utilities including air compressors, boilers, chillers, and pure steam generators feeding the block.
• Report mechanical wear or instrument drift to the engineering department and log preventive maintenance requests.

Quality & Safety

• Maintain an audit-ready shop floor by strictly adhering to current Good Manufacturing Practices (cGMP).
• Follow environmental, health, and safety (EHS) guidelines to maintain an incident-free workspace.
• Identify, report, and assist in investigating process deviations; participate in root-cause analysis and execute corrective and preventive actions (CAPA).

Shift Handover

• Formulate clear, concise shift transition summaries detailing production metrics, batch statuses, and outstanding tasks.
• Conduct a structured physical walk-through and verbal briefing with the incoming shift team.
• Ensure all active equipment logs are formally updated and closed out for the shift duration.

Key Performance Indicators

• Batch Execution Efficiency: 98% adherence to the validated batch manufacturing schedule and yield targets.
• Documentation Quality: 100% accuracy in BMR entries with zero concurrent documentation lapses or delayed entries.
• Regulatory Compliance: Zero critical/major GMP violations or non-conformances identified during internal or external audits.
• Contamination Mitigation: Achieve a zero percent (0%) batch loss rate caused by operational or sampling contamination incidents.
• Operational Continuity: Achieved via seamless, on-time shift handovers with thoroughly completed log summaries.

Candidate Profile & Technical Qualifications
Educational Architecture

• B.Sc. / B.Tech / M.Sc. in Biotechnology, Microbiology, Biochemical Engineering, or a closely related life sciences discipline.

0Reporting: Bio-Process Shift Incharge. Location: Pirangute, Pune. Shift: Rotational.