BFS Line Technician I

Description

Job Summary The BFS Line Technician I plays' a vital role in ensuring the efficient and compliant operation of Blow-Fill-Seal machinery used in the production of sterile pharmaceutical products. This position is responsible for operating, monitoring, and maintaining BFS downstream equipment, ensuring product quality, and adhering to all Current Good Manufacturing Practices (CGMP), safety regulations, and company protocols. Key Responsibilities Equipment Operation

• Set up and operate BFS downstream machinery according to established SOPs and Batch Records.
• Monitor machine performance and production output to ensure efficiency and compliance.
• Perform routine adjustments and troubleshoot minor issues to maintain continuous operation.
• Reset equipment alarms and ensure all materials are properly staged for production.

Quality Assurance & Documentation

• Accurately complete Batch Records, logbooks, setup sheets, and other documentation in a timely manner.
• Identify and escalate product quality or equipment concerns to supervisors.
• Ensure all work is completed in strict adherence to CGMP standards.
• Support investigations into deviations and assist in implementing corrective actions.
• Review MBRs and log book for accuracy and GMP standard. Safety & Housekeeping
• Adhere to all safety protocols and wear proper personal protective equipment (PPE) when needed.
• Maintain cleanroom and production areas to meet internal and regulatory cleanliness standards.
• Perform and document routine housekeeping and participate in facility inspections.

Teamwork & Communication

• Collaborate with Quality, Maintenance, Packaging, and other cross-functional teams to ensure smooth operations.
• Participate in training sessions to build technical and procedural knowledge.
• Provide guidance and training to new or junior operators as needed.

Training & Development

• Complete required training and maintain certifications in alignment with company and regulatory requirements.
• Stay updated on procedural changes and complete retraining within designated timeframes.
• Provide mentorship and training to junior machine operators and new team members in equipment operation, safety protocols, and industry best practices.

Other Duties

• Perform additional responsibilities as assigned to support production goals and departmental needs.

Qualifications & Requirements Knowledge, Skills, & Abilities

• Basic mechanical aptitude and understanding of automated manufacturing equipment.
• Ability to interpret SOPs, technical documents, and Batch Records.
• Strong attention to detail with a focus on accuracy and quality.
• Effective verbal and written communication skills.
• Team-oriented with the ability to work independently when required.
• Flexibility to work shifts, weekends, or overtime based on production needs.
• Available for 12-hour shifts (0600-1830 or 1800-0630), including nights, weekends, or holidays as needed.

Education & Experience

• High school diploma or GED required.
• Technical certifications or training in manufacturing or mechanical systems preferred.
• Previous experience in pharmaceutical or sterile manufacturing environments is a plus.
• Familiarity with BFS technology is highly desirable.

Work Conditions & Requirements

• Must be able to lift up to 50 lbs and stand for prolonged periods in a cleanroom environment.
• Must wear all required PPE, including gloves, gowns, masks, and goggles.
• Available for 12-hour shifts (0600-1830 or 1800-0630), including nights, weekends, or holidays as needed.

Why Join Nephron?

• Cutting-edge manufacturing environment
• Commitment to safety, quality, and innovation
• Growth and development opportunities
• Team-driven culture with a mission to make affordable medication accessible to all