Simtra BioPharma Solutions · 15 hours ago
Manufacturing Group Lead- Preparation (2nd Shift)
Bloomington, Indiana, United States
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies. The Prep Group Lead is responsible for coordinating activities of Preparation Operators and ensuring compliance with regulatory standards while supporting quality operations on the production floor.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Understand and follow current Good Manufacturing Practices
Assemble and operate filtration systems
Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc)
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
Write, revise and review pertinent documentation as appropriate
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will 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
Understand and follow current Good Manufacturing Practices
Assemble and operate filtration systems
Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc)
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
Write, revise and review pertinent documentation as appropriate
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required
Preferred
6 months of previous Pharmaceutical or Manufacturing experience preferred
Ability to work independently
Good communication skills
Good documentation skills, including legible handwriting
Good interpersonal skills
Basic computer skills
Basic math skills
Knowledge of aseptic manufacturing practices
Knowledge of standard operating procedures, specifications, and job-specific training materials
Requires the operations 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
Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
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 (2)
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
Inside INdiana Business
2025-09-23
Genetic Engineering News
2025-06-20
Company data provided by crunchbase