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Summary
The Machine Operator ensures 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 a Manufacturing Supervisor.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)
- Equipment Operation
- Follow and execute machine operation according to standard operating procedures (SOPs) and batch record instructions
- Understand and follow current Good Manufacturing Practices (cGMP), including legible documentation complaint with cGMP procedures
- Basic math, mechanical aptitude, and troubleshooting skills
- Read and interpret detailed equipment recipe process, high level attention to de-tail (precise measurements and sequencing)
- 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 trouble shooting 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)
- Print/document 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
- Assist 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 Supervisors, Machine Operators, etc. to update/improve SOPs
- Participate in continuous improvement initiatives
- Immediately address any safety or training deficiencies discovered by you or your team mates; notify appropriate levels of management as necessary
- Work with Engineering, Senior Technicians, Tech Services, etc. to improve material design and or equipment operation.
- Enter and verify information in logbooks, as needed
- Apply representation samples to the batch records as required
- Participate/lead stretching exercises
- Review and ensure daily 6S compliance
- Ensure all safety practices are followed and keep area clean and clear of hazards
- Identify, communicate and solve problems to ensure quality, efficiency, and safety objectives are met
- 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
- Provide direct support to test components and equipment
Job Requirements (Education and Experience)
- High school diploma or GED required
- 6 months previous Pharmaceutical Manufacturing experience preferred
- 2 years of experience operating and troubleshooting complex production equipment preferred
- Detailed instruction comprehension, including logic and analysis of data and basic math skills
- Effective communication skills
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
- Each Machine Operator level will have specific training requirements
Physical / Safety Requirements
- Must be able to lift, push/pull, and carry up to 50 pounds
- Required to stand for as long as 8 hours per day, including constant standing for 2 hours at a time
- Must be able to lift 20 pounds overhead
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate equipment is required
- Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection,
- Dexterity and physical condition to perform some level of repetitive motion tasks and maintain pace of a continuous production process
- Eyesight to ensure effective inspection of equipment and/ or filled units (corrective lenses acceptable)
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Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law – Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
Source: Indeed.com
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