Machine Operator (2nd Shift) - $19.20/hr + shift differential, benefits day oneReq # JR - 037822 Location Bloomington, Indiana, United States Job Category Assembly Jobs Date posted 05/13/2021
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The Manufacturing Operator position supports aseptic filling operations in the following areas: Capping and Preparation Operator.
Essential Duties & Responsibilities
- Understand and follow current Good Manufacturing Practices (cGMP)
- Documentation to be legible and compliant with Good Documentation Practice (GDP) procedure
- Perform routine cleanup, line clearances, and sanitizations to maintain cGMP compliance within classified work areas
- Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.
- Setup and operate equipment per applicable Standard Operating Procedures (SOPs)
- Assist in training and development of other team members
- Will be required to cross-train as a support Operator for additional areas.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
- There are minimum training requirements for each operator level.
- Ability to stand for extended periods of time.
- Ability to lift up to 50 pounds.
- Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.).
- Ability to work with chemicals to mix products and clean manufacturing areas.
- Must be able to perform overhead work (ie: sanitizing walls and ceilings).
- Physical coordination/flexibility to allow gowning for clean room environments.
- Ability to work with chemicals to mix products and clean manufacturing areas.
- Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection.
- Dexterity and physical condition to perform some level of repetitive motion tasks.
- Ability to wear respirator when product or task requires.
- Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable).
- Duties may require overtime work, including nights and weekends.
- Use of hands and fingers to manipulate office equipment is required.
- Must be able to gown qualify for Grade A/B (Filling) or for C/D (Prep, Capping, Formulation) areas.
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. 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 (40%)
- 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 (25%)
- 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
Machine Trouble shooting (15%)
- 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
Continuous Improvement, Training, and Safety (15%)
- 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
- 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.
Equipment qualification (5%)
- 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
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
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements
- Must be able to meet 20/25 corrected vision requirement and pass color blind test
- 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
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
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.