BFS Maintenance Lead: Aseptic GMP Expert

Nephron Pharmaceuticals Corporation; Columbia (SC); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in Columbia, SC seeks a BFS Maintenance Manager to lead state-of-the-art Blow-Fill-Seal maintenance across multiple platforms. You will drive reliability, safety, and regulatory compliance in a sterile manufacturing environment.

Responsibilities include strategic maintenance planning, developing a skilled technician team, overseeing changeovers and validations, and collaborating with Engineering, QA, and Production to reduce downtime and optimize performance

Qualifications

• 7+ years BFS maintenance experience with 3+ years in leadership.
• Associate degree or higher in mechanical/electrical/industrial engineering; tech certs required.
• OEM training in Rommelag, Bosch or similar preferred.

Responsibilities

• Lead and oversee BFS maintenance for multiple platforms to maximize equipment availability.
• Develop long-term overhaul planning and system upgrades.
• Monitor pneumatics, hydraulics, servos, vacuum, and compressors for optimal performance.
• Ensure readiness for changeovers, revalidations, and start-ups.
• Provide hands-on leadership to BFS Technicians and mentor training programs.
• Manage staffing, scheduling, reviews, coaching, and safety culture.
• Ensure FDA, CGMP, and SOP compliance; support deviations and CAPAs.
• Collaborate with Production, QA, and Eng to support installations and validations.

Skills

BFS maintenance leadership

Mechanical and electrical Troubleshoot

BFS equipment knowledge

Preventive & predictive maintenance

Regulatory compliance (FDA CGMP)

Cross-functional collaboration

CMMS usage

Education

Associate degree or higher in Mechanical/Electrical/Industrial Engineering

Technical trade certification in maintenance

OEM training in Rommelag, Bosch etc. preferred

Tools

Rommelag BFS platforms (324/460)

PLCs

Instrumentation & diagnostics tools

Schematic drawing interpretation

Job description

Nephron Pharmaceuticals Corporation in Columbia, SC seeks a BFS Maintenance Manager to lead state-of-the-art Blow-Fill-Seal maintenance across multiple platforms. You will drive reliability, safety, and regulatory compliance in a sterile manufacturing environment.

Responsibilities include strategic maintenance planning, developing a skilled technician team, overseeing changeovers and validations, and collaborating with Engineering, QA, and Production to reduce downtime and optimize performance