BFS Line Technician

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 initiat