BFS Filling Operator

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

The Blow-Fill-Seal (BFS) Operator is responsible for the safe, efficient, and compliant operation of BFS manufacturing equipment to produce high-quality pharmaceutical products. This role involves equipment setup, operation, in-process inspections, troubleshooting, and cleaning in accordance with GMP standards. The operator monitors critical process parameters, maintains accurate batch documentation, and collaborates with cross-functional teams to resolve issues and support continuous operations. Additional responsibilities include training new employees, supporting preventive maintenance, ensuring compliance with safety and quality standards, and contributing to process improvements and housekeeping initiatives.

• Gains and uses qualifications to perform process steps as necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
• Operates the BFS filling equipment through setup, startup, production, and cleaning. Ensures proper setup of the equipment extruder, parison, moulds, etc. during startup and makes necessary adjustments to maintain product quality and production efficiency.
• Performs in-process inspections of the product, including but not limited to fill weight measurement and calculation, vacuum leak tests, and visual and physical inspections of the product.
• Monitors and documents the critical process parameters during the manufacturing process.
• Responds promptly to any equipment issues that arise during filling production, problem-solves mechanical issues, and implements safe, compliant corrective measures to minimize manufacturing downtime.
• Assembles, disassembles, and cleans equipment and parts used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
• Escalates, notifies, and coordinates with supporting groups (Quality, Engineering, Technical Operations, R&D, etc.) and helps resolve issues.
• Performs daily review of batch documentation for accuracy and completeness. At the end of the batch, reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
• Calculates and accurately weighs the required ingredient quantities used in production based on batch record, product type, and available raw materials. Documents and labels the materials weighed.
• Works with Quality Assurance to ensure the manufacturing process meets quality specifications.
• Works with engineering team to perform preventive maintenance of BFS machines and mould change process.
• Understands the production schedules and works independently to meet the production goals.
• Trains new employees on BFS operations and trouble shooting techniques, processes, and retrains as necessary.
• Aids Section Leader in assigning qualified…