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Preparation Group Leader

2 months ago

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

The Preparation Group Leader is a key member of the Manufacturing Leadership Team at Simtra BioPharma Solutions, reporting directly to the Manufacturing Supervisor. This role provides direct support to manufacturing operations, ensuring that finished products meet the required specifications by coordinating activities of Preparation Operators in the manufacturing areas.

Key Responsibilities
  • Understand and follow current Good Manufacturing Practices (cGMP) guidelines.
  • Assemble and operate filtration systems, general production equipment, and other machinery.
  • Monitor and record critical process parameters, complete relevant paperwork, and perform routine maintenance and cleaning of production equipment.
  • Participate in Continuous Improvement Teams, train and mentor other team members, and troubleshoot process problems.
  • Assist with process/equipment validation and data analysis, and work with other groups 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 in order to comply with necessary SOPs, job-specific training materials, GMPs, and other manuals.
Work Environment

The work environment is a classified pharmaceutical environment, requiring the wearing of required gowning and Personal Protective Equipment (PPE). The role involves occasional work with water and pharmaceutical products, and the ability to work safely with materials required to produce pharmaceutical products.

Benefits

As a member of the Simtra BioPharma Solutions team, you'll 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.