Clinical Systems Specialist
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 teamsso we can solve problems in new ways.
Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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:
- Bachelors 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 youll be eligible for 1:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- Short and Long-Term Disability Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
- Voluntary Insurance Benefits
1 Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:
IC
Key Skills
- Computer Science
- Active Directory
- Computer information Technology
- PowerShell
- OS
- Windows
- Database
- SCCM
- Linux
- SAN
- Troubleshoot
- Backup
- Setup
- Technical Support
- UNIX
About Company
THIS IS WHERE IT ALL BEGAN Did you know that Baxter is the first commercial manufacturer of prepared IV solutions? It all started in 1931 in Iowa when Dr. Ralph Falk and Dr. Donald Baxter launched the Don Baxter Intravenous Products Company. Hillrom’s roots go back to when Bill Hille ... View more
