Preparation Group Leader

2 weeks ago


Bloomington, Indiana, United States Simtra BioPharma Solutions Full time
About Simtra BioPharma Solutions

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.

Our facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, offer a wide range of delivery systems, including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.

Job Summary

We are seeking a highly skilled Preparation Group Leader to join our Manufacturing Leadership Team. As a key member of our team, you will provide direct support to manufacturing, ensuring that finished products meet required specifications by coordinating activities of Preparation Operators.

You will be responsible for decision-making and oversight to ensure compliance with all regulatory agency regulations and guidelines, as well as Simtra Standard Operating Procedures.

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
  • 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
Requirements
  • High school diploma or GED required
  • 6 months of previous Pharmaceutical or Manufacturing experience preferred
  • Ability to understand, speak, read, and write English to comply with necessary SOPs, job-specific training materials, GMPs, and other manuals
What We Offer

As a member of our team, you will be eligible for a range of benefits, including medical and dental coverage, flexible spending accounts, life and AD&D insurance, and 401(k) retirement savings plan with company match.

We also offer a range of additional benefits, including paid time off, paid holidays, paid parental leave, and education assistance program.

Simtra is an equal opportunity employer and welcomes applications from diverse candidates.



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