Clinical Systems Specialist

Simtra BioPharma 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 at Simtra.  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.

 

Why join Team Simtra? Because we:

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.

 

This role:

The Clinical Systems Specialist serves as an in individual reporting unit the Clinical Operations Specialist. Responsible for developing, maintaining, and optimizing documentation that supports clinical manufacturing systems, workflows, authoring non conformance investigations and operational processes. This role blends deep technical writing expertise with hands-on understanding of clinical production environments, ensuring that complex system information is translated into clear, accurate, and user friendly materials for diverse audiences.

The ideal candidate brings strong parenteral manufacturing experience, a collaborative mindset, and the ability to work closely with clinical, technical, and regulatory stakeholders to produce high quality documentation that meets organizational, compliance, and industry standards.

 

 

The responsibilities:

• Create, edit, and maintain comprehensive documentation for clinical systems and processes, including user guides, SOPs, workflow diagrams, release notes, training materials, investigations, and technical specifications
• Collaborate with product managers, engineers, Operations team members, and quality teams to gather information and ensure documentation accuracy and completeness
• Translate complex technical and clinical concepts into clear, accessible content
• Ensure all documentation complies with regulatory, security, and quality standards relevant to clinical and healthcare environments
• Lead documentation planning for new system features, process enhancements, and integrations
• Conduct content audits to identify gaps, improve consistency, and maintain version control
• Support training initiatives by developing instructional content and assisting with knowledge transfer activities
• Serve as a subject matter expert on documentation best practices and clinical system workflows

 

 

Required qualifications:

• Bachelor’s degree or associate degree with 4 years of applicable industry experience within the parenteral manufacturing industry
• Demonstrated experience producing technical documentation for complex systems or regulated environments
• Strong understanding of clinical workflows, terminology, and system interactions
• Excellent written communication skills with meticulous attention to detail
• Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast paced environment
• Strong communication skills and problem solving abilities
• Ability to communicate effectively with both technical and non technical stakeholders
• Self directed, organized, and comfortable leading documentation initiatives
• Commitment to accuracy, clarity, and continuous improvement

 

In return, you’ll be eligible for