Operation Support Specialist - 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 – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  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.

Summary:

The Operations Support Specialist is an embedded Operations partner assigned to support manufacturing shifts within an Operations Focus Factory. The Specialist works directly with on‑shift Manufacturing and Quality colleagues during operational events to support deviation event response, capture critical details, help initiate deviations in a timely manner, and support the safe and compliant return of operations after incidents.

This role is a primary author of manufacturing deviations and is expected to write and close approximately three to four deviations per month, depending on event volume and complexity. The Specialist also owns and drives assigned CAPAs and continuous improvement actions related to manufacturing processes and provides oversight of CAPA effectiveness after implementation.

Shift: 2:30am to 11am (Monday - Friday)

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

On-shift Deviation Event Response

• Partner with Manufacturing and QA colleagues at the time of an operational event to understand what happened, what was impacted, what immediate actions were taken, and what information must be preserved for the investigation.
• Capture critical event details while the information is fresh, including timing, equipment state, batch or material identifiers, personnel involved in execution, process parameters, alarms, documentation status, environmental or area conditions, and containment actions.
• Support timely initiation of the deviation investigation process and ensure handoffs are clear when events span shifts or weekends.
• Help Operations return online after an incident by coordinating with Manufacturing, QA, Engineering, Maintenance, Validation, and other partners as appropriate, while maintaining quality and compliance expectations.
• Serve as a primary author for manufacturing deviations assigned to Operations Support.
• Write complete, clear, and technically sound investigations that include event chronology, impact assessment…