BFS Mechanic

About the Role

As the subject matter expert for the operation of Blow-Fill-Seal (BFS) equipment, the BFS Technician plays a pivotal role in ensuring the seamless and efficient production of high-quality pharmaceutical products. The role involves equipment changeovers, startup, troubleshooting, and major adjustments during ongoing production, as well as supporting maintenance activities, process optimization, and training operators on standard operating procedures (SOPs) and on-the-job training (OJT). The ideal candidate should possess technical expertise in BFS technology and demonstrate the ability to work effectively in a fast-paced manufacturing environment.

Responsibilities

• Perform efficient and accurate equipment changeovers to facilitate smooth transitions between different BFS products and configurations.
• Ensure proper setup of the BFS parison, mould, and punch during BFS startup and make necessary major adjustments to maintain product quality and production efficiency.
• Conduct fill result assessments and vacuum leak tests, ensuring the fill result meets pre-determined acceptance criteria before releasing the BFS line for production.
• Respond promptly to any issues that arise during BFS production, troubleshoot equipment malfunctions, and implement corrective measures to minimize manufacturing downtime.
• Assist in troubleshooting and making major adjustments to printers and labelers if operators are unable to resolve issues at the printing/labelling line.
• Collaborate with factory maintenance mechanics during major preventive maintenance and repairs, providing technical expertise and support.
• Continuously monitor BFS production processes and identify opportunities for improvement, implementing optimization measures to enhance efficiency and product quality.
• Revise existing SOPs and develop new ones as needed. Train operators and other team members on proper procedures to ensure adherence to best practices.
• Contribute to and conduct training sessions for BFS operators, equipping them with the necessary knowledge and skills to excel in their roles.
• Assist in investigations of deviations, incidents, non-conformances, and safety issues, contributing technical expertise and data analysis.
• Actively engage in and drive the comprehensive training program for BFS processes, including participating in best practices exchanges, industry seminars, and workgroup activities, followed by sharing the acquired knowledge through presentations.
• Understand and comply with SOPs, Environmental, Health, Safety, Regulatory, and Quality requirements.
• Support problem-solving teams to resolve production and quality issues.
• Participate in internal, regulatory, and third-party audits.
• Participate in department training as a trainer and as a trainee.
• Maintain effective working relationships with staff and personnel.
• Provide support for process improvement teams.
• Support the execution of scheduled routine preventive maintenance tasks on BFS equipment to ensure consistent and reliable operation.
• Perform routine operation tasks, such as monitoring the BFS equipment during the run, routine adjustments, weight checks, and documentation of such activities in the batch record during peak workloads or as a backup.
• Perform other duties as assigned by management to support the efficient functioning of the production process and overall organizational objectives.

Requirements

• High school diploma or equivalent with technical certifications or relevant vocational training.
• Minimum 3 years working as a Blow-Fill-Seal (BFS) Mechanic and/or understanding of BFS technology.
• Minimum 5 years of working in regulated Food / OTC Pharmaceuticals manufacturing environment; aseptic filling environment preferred.
• Excellent writing, communication, and interpersonal skills.
• Strong problem-solving skills and the ability to troubleshoot technical issues effectively.
• Familiarity with preventive maintenance procedures and routine equipment inspections.
• Detail-oriented with a commitment to ensuring quality and adherence to procedures.
• Capacity to adapt to changing priorities and work under pressure in a fast-paced production setting.
• Willingness to participate in occasional off-shift or on-call duties when required.
• Knowledge of regulatory guidelines and cGMP (Current Good Manufacturing Practices).

Physical Demands

• Flexible working hours to meet the requirements of the position.
• Able to fit and wear Personal Protective Equipment (PPE) and attire required to perform duties and assignments.
• Able to lift up to 65 pounds.
• Able to fit and wear respiratory, hearing, and other personnel protection as required for entry and work in facilities.
• Able to fit and wear cleanroom attire as required for entry and work in cleanroom facilities.
• 20/40 correctable vision.
• Able to hear well enough to converse on the radio, telephone, and in person.
• Bodily mobility to walk, bend, stand, crouch, or climb for extended periods of time.
• Able to sit and/or stand for a minimum of 8 hours per day.

Training

• Trained on specific SOPs before performing other documentation or plant-related tasks.
• Participate in cross-training as specified by the Engineering Manager to educate Engineering personnel and qualify alternates to perform assigned tasks as needed.