BFS Line Technician I

Description

• →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.

• 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.

• 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.

• 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.

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

• 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.

• 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.

• 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.