Machine Operator- Bulk Basic Skills

The Machine Operator- Bulk Basic Skills is responsible for starting, operating, cleaning, and assisting the BFS Technician in performing maintenance on production equipment. Responsible for timely documentation of work performed.

Responsibilities:

• Obtain and keep a good working knowledge, assist in performing routine, preventative, and unscheduled maintenance on the following production equipment:
  • Blow-Fill-Seal Machines
  • Resin Handling Equipment
• Preparing the BFS machines for batch filling. Tasks typically include: changing code magazines, ensuring proper filters are in place and properly tested, connecting the appropriate holding tank to the fill suite, steam sterilization, filter drying, starting the BFS and making initial mechanical and filling adjustments.
• Monitor the BFS machines and support equipment during the batch filling.
• Perform routine shift checks and document appropriately.
• Make adjustments to ampoule weight, forming, and fill volume during batch filling as needed to maintain process control.
• Performing shutdown procedures at the completion of the batch filling. Tasks typically include: disconnecting the holding tank from the fill suite, in-line WFI cleaning, internal surface cleaning, product filter integrity testing, steaming molds, and changing filters if necessary.
• Perform filter integrity test on air filters and document appropriately.
• Perform routine preventative maintenance on the BFS equipment
• Maintain housekeeping of area and equipment.
• Maintain complete and accurate documentation of activities to support product disposition.
• Participate in the internal and external training program.
• Maintain a professional team-oriented working relationship with fellow employees.
• Follow Holopack SOPs, safety and health guidelines and c-GMP Guidelines.
• Perform routine maintenance on BFS machines.

Physical Requirements:

• Ability to frequently lift and carry up to 40 pounds of equipment, parts or supplies.

Qualifications:

• 2 year technical degree or equivalent experience in a manufacturing environment
• Mechanical or electrical experience in a manufacturing environment.
• Ability to establish priorities and operating equipment quality expectations.
• Ability to participate and develop a team-oriented working relationship within the operation.