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