About this role
1.0 Major Job Responsibilities
• Execute Formulation and Compounding: Setup, operate, and monitor equipment used for compounding, mixing, and filtration of parenteral solutions according to the Batch Manufacturing Record (BMR).
• Operate Filling Lines: Run and manage aseptic or non-aseptic filling machines, barrier isolators, and closing/sealing equipment under strict environmental controls.
• Perform Component Preparation: Prepare, wash, and sterilize container-closure components (vials, ampoules, syringes, stoppers) prior to filling.
• Conduct In-Process Checks: Monitor critical machine operations such as fill volume accuracy, bubble-free filling, and container integrity checks at scheduled intervals
• Perform Rigorous Line Clearance: Complete full cleaning, disinfection, and line clearance protocols before starting a new batch to guarantee zero cross-contamination
• Troubleshoot & Adjust Equipment: Respond to equipment alarms, perform basic mechanical troubleshooting, and adjust machine settings to maintain validated parameters
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2.0 Quality & cGMP Responsibilities
• Ensure Aseptic Discipline: Maintain strict aseptic behaviors, personnel flows, and follow validated Grade A/B gowning procedures if assigned to core processing areas.
• Execute Real-Time Documentation: Complete batch records, machine logs, and secondary cleaning forms accurately at the time of operation following data integrity rules.
• Adhere to Regulatory Frameworks: Perform all activities in strict compliance with EU GMP Annex 1, US FDA guidance, and the facility’s internal Pharmaceutical Quality System.
• Manage Material and Component Control: Verify material labels, quantities, and expiration dates before introduction to production, minimizing batch waste.
• Escalate Process Deviations: Stop production and immediately report any non-conformance, temperature variation, or particulate spike to the supervisor
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3.0 Environment, Health, & Safety (EHS) Responsibilities
• Utilize Mandated PPE: Wear designated protective gear including specialized sterile gowns, safety glasses, chemical-resistant gloves, or thermal protection where necessary.
• Follow Hazardous Energy Control (LOTO): Strictly apply Lockout/Tagout procedures prior to clearing any mechanical line jams or executing basic maintenance.
• Maintain Workspace Cleanliness: Practice consistent housekeeping to keep emergency exits, eye-wash stations, and fire equipment unblocked.
• Report Hazards and Incidents: Proactively report near-misses, structural leaks, unsafe behaviors, or unexpected material exposure to the EHS department.
• Practice Ergonomic Material Handling: Employ correct lifting and movement techniques when handling high-capacity material bins or heavy component trays to protect against injury