Teams at Simtra BioPharma Solutions

Manage and lead risk management activities for non-conformances, complaints, change controls, equipment/validation and process changes. Author and approve risk assessments, FMEAs, deviations, CAPAs; support regulatory inspections and cross-functional remediation. Use statistical tools and lead continuous improvement of risk management procedures.

Lead supply chain planning for assigned business segment, maintain executable production schedules, drive S&OP/operating reviews, lead cross-functional improvement initiatives, and mentor planning team members to meet manufacturing objectives.

Lead engineering execution and technical oversight for capital projects in a GMP pharmaceutical facility. Manage scope, budgets, schedules, risk, contractor deliverables, and cross-functional coordination from concept through commissioning. Develop project documentation (URS, RFQs, P&IDs, CERs), support external engineering design reviews, and implement continuous improvement while ensuring compliance with quality and safety requirements. 100% onsite in Bloomington, IN.