Production - BFS Operator - LVP

Department: Production
Reporting To: Manager – Production
Industry: Pharmaceutical / Sterile Manufacturing
Experience: 5–10 Years
Qualification: ITI / Diploma / B.Pharm / B.Sc. (Technical)

Job Summary

Responsible for optimizing BFS production processes through effective supervision, preventive and breakdown maintenance, and robust documentation practices. The role ensures smooth production operations, high equipment availability, compliance with cGMP requirements, and readiness for regulatory audits.

Key Responsibilities:

1. Production Process Optimization

• Improve production efficiency through routine inspections, preventive maintenance, and calibration to minimize downtime.
• Supervise daily BFS production activities to ensure operational efficiency and output quality.
• Collaborate with cross-functional teams (QA, QC, Engineering, Validation) to optimize manufacturing processes and resolve technical issues.
• Coordinate production engineering activities to ensure consistent and high-quality output.

2. Equipment Maintenance & Troubleshooting

• Perform preventive and breakdown maintenance of BFS (Blow-Fill-Seal) machines.
• Execute routine maintenance activities such as lubrication, inspection, alignment, and minor repairs.
• Troubleshoot and diagnose complex mechanical, electrical, and process-related issues to ensure uninterrupted production.
• Conduct regular equipment inspections and recommend maintenance improvements or upgrades.
• Maintain detailed maintenance records, including repairs, spare parts usage, and machine history.
• Perform mould changeovers for different pack sizes (500 ml, 250 ml, and 100 ml).

3. Documentation Management

• Prepare, review, and update Standard Operating Procedures (SOPs) related to production and maintenance.
• Prepare Master Preventive Maintenance Plans for production equipment.
• Maintain and review equipment operation and preventive maintenance logbooks.
• Review filling-related sections of Batch Manufacturing Records (BMRs) for accuracy and compliance.
• Ensure proper archiving, traceability, and retrieval of documents for audits and inspections.
• Prepare and support documentation for regulatory audits and inspections.
• Review documentation for accuracy, completeness, and GMP compliance.
• Coordinate with Quality Assurance (QA) for deviations, change controls, and CAPA activities.
• Ensure batch records are properly reviewed and completed prior to product release.

4. Coordination & Communication

• Work closely with Production, QA, QC, and Validation teams for smooth operations and documentation flow.
• Support investigations related to deviations, non-conformances, and customer complaints.
• Provide training to operators and staff on equipment operation, documentation practices, and GMP compliance.
• Identify and implement continuous improvement initiatives in production and documentation practices.
• Stay updated with current regulatory guidelines and industry trends related to sterile manufacturing and documentation.
• Support internal and external audits by providing required documentation and technical explanations.

Machine Exposure / Hands-on Experience

• STERIMAX BFS 8166
• STERIMAX BP 360
• BREVETTI ANGELA SYFPAC BFS Machine
• BFS 7510
• HUNAN GLADDEN ISBM Machine

Key Skills & Competencies

• Strong expertise in BFS technology and sterile manufacturing
• In-depth knowledge of preventive & breakdown maintenance
• Excellent GMP documentation and audit readiness
• Problem-solving and root cause analysis skills
• Effective communication and team coordination
• Ability to train and mentor technical staff

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹50,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person