Preparation Group Leader (3rd Shift)

Job Description

Simtra BioPharma Solutions is seeking a Prep Group Lead for their Bloomington, Indiana facility. This role is a member of the Manufacturing Leadership Team reporting to the Manufacturing Supervisor. The Prep Group Lead provides direct support to manufacturing, ensuring finished products meet specifications by coordinating the activities of Preparation Operators in manufacturing areas. They ensure compliance with regulatory guidelines and Simtra's Standard Operating Procedures and drives quality operations on the production floor.Responsibilities include:

• Understanding and following current Good Manufacturing Practices.
• Assembling and operating filtration systems.
• Operating general production equipment (autoclaves, vial washers, depyrogenation ovens, etc.).
• Monitoring and recording critical process parameters.
• Completing paperwork following GDP/GMP guidelines.
• Performing routine maintenance and cleaning of production equipment.
• Participating on Continuous Improvement Teams.
• Training and mentoring team members.
• Troubleshooting process problems and responding to process alarms.
• Assisting with process/equipment validation and data analysis.

Requirements:

• High school diploma or GED.
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Ability to work independently.
• Good communication and documentation skills.
• Basic computer and math skills.
• Knowledge of aseptic manufacturing practices and standard operating procedures.

Simtra offers:

• Day One Benefits.
• Medical & Dental Coverage.
• Flexible Spending Accounts.
• 401(k) Retirement Savings Plan with Company Match.
• Time Off Program.
• Paid parental leave.
• Employee Assistance Program.