What are the responsibilities and job description for the BFS Line Technician position at NEPHRON SC, LLC?
Description
Corporate Statement:
Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.
As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.
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Job Purpose: (in addition to the duties of a Machine Operator)
The BFS Technician is a critical role within the pharmaceutical manufacturing process, responsible for the operation, maintenance, and troubleshooting of Blow-Fill-Seal (BFS) machines. This position serves as a mid-level technical expert on the BFS production line, handling more complex issues and ensuring that all equipment runs efficiently and complies with CGMP and regulatory standards. The Technician will work closely with the machine operator and the engineering team to resolve equipment malfunctions, perform routine and preventive maintenance, and ensure product quality and process continuity. In addition, the Technician may assist in training and mentoring junior staff and contribute to continuous improvement initiatives in the manufacturing process.
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Essential Duties and Responsibilities:
BFS Equipment Operation:
Ø Operate and monitor Blow-Fill-Seal (BFS) machines to produce sterile pharmaceutical products, ensuring equipment performs optimally according to production schedules.
Ø Meet production targets while executing efficient changeovers, performing accurate BFS interventions aligned with audit trail activities, and adhering to required maintenance and aseptic techniques.
Preventive Maintenance:
Ø Conduct routine maintenance and troubleshooting of BFS equipment to minimize downtime.
Ø Quickly identify and resolve mechanical, electrical, or process-related issues to maintain production flow.
Quality Control & Compliance:
Ø Ensure all manufactured products meet internal quality specifications and comply with regulatory requirements.
Ø Perform inspections, quality checks, and testing in accordance with CGMP standards.
Ø Participate in annual Media Fill tests as required.
Ø Review MBRs and log book for accuracy and GMP standard.
Troubleshooting & Problem Solving:
Ø Serve as the primary point of contact for resolving BFS equipment issues, including those related to mechanical, electrical, and process performance.
Ø Collaborate with maintenance and continuous improvement teams to implement corrective actions effectively.
Documentation & Reporting:
Ø Maintain detailed and accurate records of equipment maintenance, repair activities, and production logs.
Ø Ensure all documentation aligns with CGMP and established Procedures, Forms, and Master Batch Records.
Safety & Cleanliness:
Ø Promote and enforce safety policies, ensuring a secure work environment.
Ø Ensure cleanroom and production areas align with procedural standards and cleanliness.
Ø Ensure daily housekeeping is maintained by verifying logs and conducting facility or area walk throughs.
Process Improvement:
Ø Contribute to continuous improvement initiatives by providing feedback on equipment performance, process adjustments, and potential efficiency enhancements.
Training & Development:
Ø Mentor and train junior BFS Technicians and new team members on equipment operation, safety procedures, and best practices.
Ø Must maintain current training and certifications in compliance with company and regulatory requirements.
Supplemental Functions:
Ø Performs all other duties as assigned or apparent.
Job Specifications and Qualifications:
Knowledge:
Ø Proficient in the operation, troubleshooting, and maintenance of BFS equipment.
Ø Strong knowledge of mechanical, electrical, and pneumatic systems.
Ø Familiarity with process automation and control systems used in BFS manufacturing.
Ø Experience in sterile manufacturing environments and understanding of aseptic techniques.
Ø Strong understanding of FDA regulations, GMP, and other relevant industry standards.
Ø Excellent written and verbal communication skills, with the ability to interact effectively with team members and management.
Ø Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing issues.
Ø Experience with data analysis tools and systems related to production performance.
Education / Experience:
Ø High school diploma or equivalent required. Technical degree or certification in Mechanical/Electrical Engineering, Industrial Maintenance, or a related field is preferred.
Ø Minimum of 3-5 years of hands-on experience with Blow-Fill-Seal machines in a pharmaceutical manufacturing or GMP-compliant environment.
Licensing and Certifications:
Ø Certification in Lean Manufacturing, Six Sigma, or similar process improvement methodologies.
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Working Conditions / Physical Requirements:
Ø Ability to lift and carry heavy equipment (up to 50 lbs), stand for extended periods and work in a cleanroom environment.
Ø Comfortable wearing personal protective equipment (PPE), such as gloves, gowns, masks and goggles.
Ø Salary range: Based on experience.
Ø Hours of Work: 12-hr shift work (0600-1830, 1800-0630).
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The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.
Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals is a drug free workplace.
