JOB SUMMARY:
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 BFS Technician will be responsible for equipment changeovers, startup, troubleshooting, and major adjustments during ongoing production. Additionally, the role involves supporting maintenance activities, process optimization, and training operators on standard operating procedures (SOPs) as well as 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.
DUTIES AND RESPONSIBILITIES:
- Equipment Changeovers: Perform efficient and accurate equipment changeovers to facilitate smooth transitions between different BFS products and configurations.
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BFS Startup and Major Adjustments: 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.
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Fill Assessment and Vacuum Leak Test: Conduct fill result assessments and vacuum leak tests, ensuring the fill result meets pre-determined acceptance criteria before releasing the BFS line for production.
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Troubleshooting: Respond promptly to any issues that arise during BFS production, troubleshoot equipment malfunctions, and implement corrective measures to minimize manufacturing downtime.
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Printer and Labeler Support: Assist in troubleshooting and making major adjustments to printers and labelers if operators are unable to resolve issues at the printing/labelling line.
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Support Factory Maintenance Mechanics: Collaborate with factory maintenance Mechanics during major preventive maintenance and repairs, providing technical expertise and support.
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Process Optimization: Continuously monitor BFS production processes and identify opportunities for improvement, implementing optimization measures to enhance efficiency and product quality.
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SOP Development and Training: Revise existing SOPs and develop new ones as needed. Train operators and other team members on proper procedures to ensure adherence to best practices.
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BFS Operator Course: Contribute to and conduct training sessions for BFS operators, equipping them with the necessary knowledge and skills to excel in their roles.
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Support Investigations: Assist in investigations of deviations, incidents, non-conformances, and safety issues, contributing technical expertise and data analysis.
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Training and Development: The BFS Mechanic plays a pivotal role in actively engaging and driving the comprehensive training program for BFS processes. This encompasses targeted training initiatives, such as participating in best practices exchanges, industry seminars, and workgroup activities, followed by sharing the acquired knowledge through presentations, with the aim of enhancing the organization's overall understanding and proficiency in BFS technology. By taking the lead in fostering a culture of continuous learning, the BFS Mechanic contributes to the continuous improvement and excellence of our production operations.
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Compliance: This individual understands and complies with SOPs, Environmental, Health, Safety, Regulatory and Quality requirements.
SUPPORTIVE FUNCTIONS
In addition to the performance of the essential functions, this individual may be required to perform a combination of the following supportive functions, with the percentage of time performing each function to be solely determined by the supervisor based upon the requirements of the plant:
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Team member for problem solving to resolve production and quality issues.
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Participation in internal, regulatory and third-party audits.
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Participates in department training as a trainer and as a trainee.
- Keep effective working relationship with the staff and personnel contacted in the course of duties.
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Provides support for process improvement teams.
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Support the execution of scheduled routine preventive maintenance tasks on BFS equipment to ensure consistent and reliable operation.
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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 will be supported by BFS Mechanics during peak workloads and as a backup while BFS operators are absent during paid time off or sickness.
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The BFS Mechanic may be assigned other duties as needed or directed by the management to support the efficient functioning of the production process and overall organizational objectives.
SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES
The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of knowledge, skills, and abilities:
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Must possess excellent writing, communication, and interpersonal skills.
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Strong problem-solving skills and the ability to troubleshoot technical issues effectively.
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Familiarity with preventive maintenance procedures and routine equipment inspections.
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Detail-oriented with a commitment to ensuring quality and adherence to procedures.
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Capacity to adapt to changing priorities and work under pressure in a fast-paced production setting.
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Willingness to participate in occasional off-shift or on-call duties when required.
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Knowledge of regulatory guidelines and cGMP (Current Good Manufacturing Practices).
- Must be flexible in terms of working hours to meet the requirements of the position.
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Must be able to fit and wear Personal Protective Equipment (PPE) and attire required to perform duties and assignments.
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Must be able to lift up to 65 pounds.
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Must be able to fit and wear respiratory, hearing, and other personnel protection as required for entry and work in New Vision Pharmaceuticals facilities.
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Must be able to fit and wear cleanroom attire as required for entry and work in the New Vision Pharmaceuticals cleanroom facilities.
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Must have 20/40 correctable vision.
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Hear well enough to converse on the radio, telephone and in person.
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Bodily mobility to walk, bend, stand, crouch, or climb for extended periods of time.
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Must be able to sit and/or stand for a minimum of 8 hours per day.
TRAINING
- The BFS Mechanic to be trained on the specific SOPs before performing other documentation or plant related tasks.
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The BFS Mechanic to be participating in cross-training as specified by the Engineering Manager.
- This program educates Engineering personnel and qualifies alternates to perform assigned tasks as needed to support manufacturing activities, relieve personnel constraints, support investigations, etc.
- Education:
High school diploma or equivalent with technical certifications or relevant vocational training.
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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.
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Grooming:
All employees must maintain a neat, clean, and well-groomed appearance per company standards.
