For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, at Simtra, there is a strong emphasis on quality and continuous improvement. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Summary

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.

Essential Duties and Responsibilities:

1. 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

2. 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
• 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

3. 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
• 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

4. 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

5. 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

6. Other

• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required
• Visual acuity 20/20 with or without corrective vision and ability to pass color blind test
• Ensure all safety practices are followed and keep area clean and clear of hazards

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.

Qualification Requirements: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:

• 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.

Education and Experience: High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.

Language Skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP', job-specific training materials, GMP's, and other manuals.

Physical Demands

• Occasional (0-33%)
• Walking, climbing stairs and ladders,overhead reaching and/or lifting, balancing, kneeling, crouching, crawling
• Lifting up to 38 lbs
• Carrying 30 lbs
• Frequent(34-66%)
• Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls
• Lifting and carrying up to 32 lbs
• Pushing and pulling up to 16 lbs

Additional Requirement: Final candidates for Machine Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra 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
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Reasonable Accommodations

Simtra 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 and let us know the nature of your request along with your contact information.

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