Machine Operator - Shift 3

Shift Information

Shift 3 Hours: 10:45PM-6:45AM

Responsibilities

• Equipment Operation
• Follow and execute machine operation according to standard operating procedures (SOPs) and batch record instructions
• Maximize equipment efficiency during operation, ensuring first pass quality product
• Periodically check/examine units from good and or reject areas to ensure proper equipment function
• Challenge equipment and or verification systems according to SOPs or batch record instructions
• Document all actions performed at the time of performance; assist with verifying various batch record or other equipment steps for teammates
• Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel
• Contact and work with internal resources and or vendors to maintain/improve equipment performance
• Meet equipment/line efficiency targets by proactively taking action to prevent downtime; work with upstream or downstream team members to help line flow
• Use and sample printed materials to the batch record by First In First Out (FIFO) machine outputs or reports before, during, or after processing
• Set-up, Tear down, & Changeover
• Thoroughly clean and clear machines in established target timelines between production operations
• Perform set-up and changeover activities independently for assigned machine; assist set-up and or changeovers on additional equipment when available
• Verify all set-up/changeover steps have been completed properly using set-up checklists
• Maintain setup and changeover process to ensure completion within target set/changeover time
• Assist Quality Assurance and or production clearance personnel with clearance of machine
• Machine Trouble Shooting
• Track machine faults and or downtime system data as problems occur; share information with Technician/Maintenance/Engineering support and help recommend appropriate action to correct the equipment issue
• Clear most faults and re-start equipment following shutdown with minimal direction or supervision according to SOPs or batch record instructions
• Absorb and complete work orders for equipment related problems
• Provide recommendations and implement solutions to equipment/process challenges
• Utilize all available information and support groups to resolve problems in a timely manner with documentation and follow up to problems with inadequate/defect material
• Continuous Improvement, Training, and Safety
• Train peers and Relief Machine Operators for general equipment operation, setup and changeover
• Work with Finishing Training, Supervisors, Machine Operators, etc. to update/improve SOPs
• Immediately address any safety or training deficiencies discovered by you or your team mates; notify appropriate levels of management as necessary
• Equipment Qualification
• Provide support to equipment qualification/validation
• Develop SOPs for equipment implementation
• Work with Tech Services, Engineering, Maintenance and Production to ensure smooth transition to production use direct support to test components and equipment

Physical / Safety Requirements

• Occasional (0-33%): Walking, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling
• Frequent (34-66%): Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls
• Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Work Environment

Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work in a team environment on a variety of automated packaging equipment.

Desirable Qualifications

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the usage of hand tools for set up and operation of automated equipment.