Sr. Technical Writer - Clinical Mfg

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.

The Sr. Technical Writer is responsible for performing site Non‑Conformance Report (NCR), Significant SNCRs investigations, authoring CAPAs, standard operating procedures (SOPs), Clinical Batch Records, and miscellaneous technical transfer documentation as needed. This role will also play a critical role supporting training for operators. The candidate will execute these investigative tasks utilizing tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions, related effectiveness criteria.

Functioning in an interdepartmental capacity, this individual will author Batch records and technical documentation alongside Manufacturing and Technical Transfer personnel. Personnel filling this role will be supporting the Development and Pre‑Commercial Services (DPCS) group within the Bloomington facility. The initial scope of role will be to perform duties as described with the opportunity to build a scalable organization of direct reports in the future.

This candidate will sit onsite at the Bloomington facility and report to the Director of DPCS.

• Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation.
• Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams.
• Provide relevant experience for training manufacturing and technical personnel both directly and indirectly.
• Establish a scalable framework and organization for execution of technical and quality documentation.
• Determine the Define/Measure/Analyze (problem‑solving technique) elements of the investigation by utilizing investigation tools.
• Identify cross‑functional team members and assemble the investigation/authoring teams.
• Confirm corrections/containment identified based on the investigation results.
• Determine the appropriate data sources to be evaluated for the investigation and obtain the required data.
• Investigate the root cause(s) of the issue and document the investigation results.
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle.
• Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the…