Jobs at Simtra BioPharma Solutions

Manage and lead a process engineering team supporting aseptic filling and packaging of sterile injectables. Oversee projects, capital budgets, equipment procurement/installation, validation, change control, SOPs, lean improvements, hiring/coaching, and ensure cGMP compliance and on-time delivery.

The Manufacturing Technical Services Representative manages commercial master batch records, trains staff, investigates non-conformance, and collaborates with multiple teams on projects.

Manage an engineering compliance team to ensure GMP compliance across Engineering and Maintenance. Drive closure of deviations, CAPAs, change controls, and audit readiness; support regulatory inspections and client audits; maintain facility documentation, ERP asset creation, and pest control trending; hire, coach, and develop staff.

The Automation Engineer is responsible for designing, implementing, optimizing, and maintaining automation systems in pharmaceutical processing, ensuring compliance and efficiency in operations.

The Process Engineer will develop, implement and optimize manufacturing packaging processes, ensuring regulatory compliance and improving efficiency in aseptic manufacturing.

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The Technical Services Director oversees technical transfer and validation operations, ensuring compliance and leading cross-functional teams to enhance aseptic manufacturing processes.

The CAPA Manager oversees the Corrective and Preventive Action system ensuring compliance with regulations, leads investigations, analyzes quality data, and collaborates with cross-functional teams to enhance quality performance.

Leads enterprise infrastructure strategy, architecture, incident escalation, cloud and on-premises operations, networking, security, backup, monitoring, and ITSM processes. Oversees validated and non-validated systems in a regulated GMP and 21 CFR Part 11 environment, partners with OT and laboratory teams, manages vendors and major incidents, mentors engineers, and drives infrastructure improvements across manufacturing operations. This onsite role includes 24/7 on-call participation and occasional travel.

Lead technical onboarding and process development for new sterile injectable drug products. Guide cross-functional teams through development studies, PPQ/clinical batches, tech transfer documentation, and hand-off to commercial. Provide manufacturing floor support, investigate deviations, manage CAPA and change control, qualify processes and gowning, represent Simtra in audits, and mentor MSAT staff.

Develop and maintain a balanced 90-day production plan, coordinate filling/finishing work orders in the ERP, analyze capacity and demand, manage master data and the Compass database, produce performance metrics, and create shipping schedules while collaborating with manufacturing and cross-functional teams.

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.