Jobs at Simtra BioPharma Solutions

• Perform batch record review and final product release / disposition for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.

• Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.

• Act as the final/highest-level escalation point and the point of contact for external vendor escalations for infrastructure support tickets and complex issues, including network outages, major incidents, or system failures. Use ServiceNow to manage incidents, service requests, and changes adhering to established SLAs and ITSM processes and providing professional and quality service.

• Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools

• Day One Benefits

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

• Single point of Quality Operations accountability for the assigned Focus Factory, from manufacturing readiness through batch disposition and release.
• Provides independent quality oversight and quality decision-making for routine operations, escalations, deviations, CAPA effectiveness, and inspection readiness.

• Safely load and unload trucks; verify BOL/packslip accuracy and assess for damages.
• Properly pack materials for shipment, including use of FedEx/UPS systems.

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes

• Responsible for maintaining departmental headcount and all associated administrative and planning functions, including interviewing candidates, hiring, onboarding & training, personnel development, performance management, scheduling, directing day-to-day activities and project oversight
• Responsible for equipment performance, preventive/scheduled maintenance, emergency maintenance,...