Simtra BioPharma Solutions · 6 hours ago
Formulation & Preparation Operator
Bloomington, Indiana, United States
Full-time
Onsite
New Grad, Entry Level
0+ years expSimtrabps is seeking a Formulation & Preparation Operator to support aseptic filling operations. The role involves staging and delivering components, conducting in-process testing, and ensuring compliance with Good Manufacturing Practices and Good Documentation Practices.
HealthcarePharmaceuticalManufacturingBiopharmaMedical
Responsibilities
Understand and follow current Good Manufacturing Practices (GMP)
Understand and follow current Good Documentation Practices (GDP)
Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas. Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule
May be required to cross train as a support operator to assist additional manufacturing areas
Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches
Perform routine verification of equipment and instruments
Compare Lot numbers to ensure correct components are being used for the specified batch
Complete calculations to support preparation and formulation activities
Retrieve and test in-process samples
Clean, Sterilize, and sample equipment
Setup and operate autoclaves, parts washers, tank cleaning, and formulation stations in Cleanroom areas
Assist in the training and development of other team members
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime may be required
Qualification
Required
High school diploma or GED required
Must be able to understand, speak, read and write English in order to comply with necessary SOP's, job-specific training materials, GMP's, and other manuals
Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.)
Must have the ability to work effectively in a 'hands on environment' capable of troubleshooting complex equipment and systems
Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices
Ability to demonstrate proficiency in reading equipment drawings
Ability to work safely with equipment under pressure
Must be able to lift and carry up to 70 lbs, and push and pull up to 150 lbs
Extended periods of standing and/or walking
Extended periods in Grade A, B, C, D production environments
Use of hands and fingers to manipulate equipment is required
Preferred
6 months of previous Pharmaceutical or Manufacturing experience preferred
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase