Manufacturing Group Lead- Aseptic Filling; 3rd Shift

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 – all directly injected into patients worldwide. There is a strong emphasis on quality and continuous improvement at Simtra, and we hold 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.

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams so we can solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
• Make it COUNT – We take pride in our day‑to‑day work, knowing the impact we make – taking on challenges big and small to improve patient health.

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 that 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.

• 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 before 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.
• Scheduled weekend overtime will be required.

Classified pharmaceutical environment wearing 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…