Aseptic Manufacturing Risk Management Associate II

Simtra Bio Pharma Solutions (Simtra) is a world‑class contract development manufacturing organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. Our facilities are located in Bloomington, Indiana, US and Halle/Westfalen, Germany, and 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 portfolio includes biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, and vaccines, all of which are directly injected into patients worldwide. With a strong emphasis on quality and continuous improvement, we hold ourselves to the highest g‑MP and regulatory standards.

While our primary focus is cGMP manufacturing, we also provide support services such as 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.

The Technical Services Associate II (Risk Management) is responsible for risk‑management activities associated with non‑conformances, complaints, equipment validation, qualification, and change‑control activities at the BPS site. This position interacts with clients, regulatory agencies, and cross‑functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents. The role reports to the Technical Services Validation Sr. Manager.

• Provide guidance and technical expertise on regulatory requirements and company risk‑management processes.
• Assess risks associated with non‑conformances, complaints, audits, and change controls, and update process FMEAs as needed.
• Review and approve risk assessments submitted through investigations, complaints, audits, change controls, and other quality‑system activities.
• Author and approve risk assessments related to equipment, manufacturing‑process changes, facility modifications, and construction projects.
• Author and approve deviation reports related to product and process issues.
• Lead and support risk‑management activities for engineering, manufacturing, and process‑improvement projects.
• Serve as the site subject‑matter expert (SME) for risk‑management and provide guidance for risk‑remediation activities.
• Support risk assessments for new processes and validation projects.
• Utilize statistical tools to evaluate and analyze risk and process data.
• Perform annual reviews and updates of site process FMEAs to ensure continued effectiveness.
• Initiate, lead, and manage CAPAs and change‑control activities.
• Participate in regulatory inspections, audits, and compliance‑related inquiries.
• Contribute to the development, maintenance, and continuous improvement of risk‑management procedures and practices.

• Bachelor’s degree, preferably in a science or engineering related field.
• Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing.
• American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification is a plus.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include JDE, Pilgrim, Veeva, Trackwise, etc.).

• Must be able to wear appropriate personal protective equipment.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Must be able to gown for Grade C area.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life 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
  • Short and…