Machine Operator - Shift 3

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled 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, there is a strong emphasis on quality and continuous improvement at Simtra. 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. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

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

The 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

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

T rack 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

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…