Filling Group Leader (3rd Shift)

Job Description

Simtra BioPharma Solutions is seeking a Filling Group Leader for their Bloomington, Indiana facility. The Filling Group Leader will report to the Manufacturing Supervisor and provide direct support to manufacturing, ensuring finished products meet specifications. This role involves coordinating the activities of Filling Operators and ensuring compliance with regulatory guidelines and Simtra's Standard Operating Procedures. The Filling Group Leader fosters a team-oriented environment focused on productivity, safety, and quality.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. They offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.Responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency.
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production.
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior.
• Required to maintain attendance in accordance with the Bloomington Attendance Policy.
• Scheduled weekend overtime will be required.

Requirements:

• High school diploma or GED required.
• 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/Subject Matter Expert.

Simtra BioPharma Solutions offers:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental 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
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Voluntary Insurance Benefits
• Onsite Campus Amenities: Workout Facility, Cafeteria, Credit Union