Machine Operator - Shift 3

Simtra BioPharma Solutions•Bloomington, IN

3d•Onsite

About The Position

The Machine Operator works within the Finishing/Packaging Complex. They ensure maximum equipment efficiency to meet client demand and expectations. They contribute to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. Machine Operators will support Manual Inspection and Packaging operations when necessary. This position reports to the Finishing Supervisor. Shift 3 Hours: 10:45PM-6:45AM

Requirements

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
Visual acuity 20/20 with or without corrective vision and ability to pass color blind test
High School diploma or GED
6 months of previous Pharmaceutical or Manufacturing experience preferred
Must be able to understand, speak, read and write English in order to comply with necessary SOPs, job-specific training materials, GMPs, and other manuals

Responsibilities

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
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
Monitor setup and changeover process to ensure completion within target set/changeover time
Assist Quality Assurance and or production clearance personnel with clearance of machine
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
Assist with completing 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
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
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
Maintain attendance in accordance with the Bloomington Attendance Policy
Ensure all safety practices are followed and keep area clean and clear of hazards