Filling Group Leader Weekend PM

About Simtra Bio Pharma Solutions

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. We place a strong emphasis on quality and continuous improvement, holding ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services, including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life‑changing medicines to patients worldwide.

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas. The Filling Group Leader provides decision‑making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.

This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. This position is required to work all designated plant holidays.

Weekend PM Friday‑Sunday 7:00 pm‑7:30 am. Scheduled weekend overtime will be required.

• 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.
• Maintain attendance in accordance with the Bloomington Attendance Policy.

Classified pharmaceutical environment requiring required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Must be able to occasionally (1‑33% of the time) work in a confined/clustered workspace.

• 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
  • 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

• Occasional (1‑33%)
  • Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
  • Lifting and carrying up to 70 lbs
  • Pushing and pulling up to 35 lbs
• Frequent (34‑66%)
  • Standing, walking, reaching forward and…