BFS Maintenance 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: 

The BFS Maintenance Technician 1 is an entry-level role focused on assisting with the operation and basic maintenance of Blow-Fill-Seal (BFS) equipment. This role supports senior technicians and line mechanics by performing routine preventive maintenance, documenting work activities, and helping resolve minor mechanical and electrical issues. The Technician 1 ensures operations meet CGMP and safety standards while gaining hands-on experience in sterile pharmaceutical manufacturing. _________________________________________________________________________________________

Essential Duties and Responsibilities:

Equipment Support & Basic Maintenance:

Ø Assist in the operation and routine maintenance of BFS production equipment.

Ø Perform basic troubleshooting under supervision (e.g., minor jams, adjustments).

Ø Support changeovers and machine setups.

Ø Help identify and report unusual machine behavior or defects.

Compliance & Documentation:

Ø Follow all CGMP and FDA guidelines in cleanroom and production areas.

Ø Complete maintenance logs and standard forms accurately and on time.

Ø Support SOP adherence and equipment checklists during each shift.

Training & Development:

Ø Participate in on-the-job training under guidance from BFS Maintenance Technician 2 or Supervisor.

Ø Learn technical fundamentals of BFS equipment, cleanroom and compliance procedures.

Ø Attend assigned training and demonstrate growing mechanical competence.

Safety & Cleanroom Expectations:

Ø Follow all safety rules and lockout/tagout procedures.

Ø Wear appropriate PPE and comply with gowning requirements including proper aseptic technique.

Ø Sanitize tool, equipment and area as necessary by procedures. 

Job Specifications and Qualifications: 

Knowledge:

Ø Basic understanding of mechanical or electrical systems.

Ø Willingness to learn BFS equipment and maintenance practices.

Ø Familiarity with tools, safety procedures, and production environments.

Education / Experience:

Ø High school diploma or GED required.

Ø 1–2 years of experience in a manufacturing, maintenance, or technical support role preferred.

Ø Prior BFS experience preferred; training provided.

Licensing and Certifications:

Ø Technical certification in maintenance, electrical, or mechanical systems preferred but not required.

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Working Conditions / Physical Requirements:

Ø Ability to lift up to 50 – 70 lbs, bend, reach, and stand for extended periods.

Ø Must be able to work in a cleanroom setting with appropriate PPE.

Ø 12-hour rotating shifts (2-2-3 schedule); shift assignment may vary.

Ø Salary range: Based on experience.

Ø May be asked to participate in on-call rotation.