Jobs at Simtra BioPharma Solutions

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. This position 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 required, 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 a plus.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Veeva, Trackwise, etc.)

Physical / Safety Requirements:

• 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