Principal Technical Writer

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 Principal 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.

The responsibilities:

• 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 Action Plan/Effectiveness Plan\
• Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)
• Manage multiple investigations at any given time
• Responsible for speaking to clients and regulatory authorities to explain investigations

Required qualifications:

• BS degree required, preferably in a science or technical area or equivalent experience
• 5+ years technical writing experience, preferably in pharmaceutical industry
• Demonstrate direct and indirect leadership ability
• Knowledge of applicable CAPA procedures, specifications, regulations and standards
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
• Goal-setting, prioritize, organization, attention to detail, and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)\
• Ability to utilize enterprise software systems (Trackwise)

Physical / safety requirements:

• Duties will require overtime work, including nights and weekends on occasion
• Ability to gown in C/D gowning area

In return, you'll 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
    
    
    
    
  
  
  
  

[1] Current benefit offerings are in effect through 12/31/25

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 Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/