Experteer Overview
In this role you will serve as the technical expert for aseptic filling and isolator technology, guiding operations to meet GMP and regulatory standards. You will lead cross-functional technical activities, drive process robustness and continuous improvement, and support audits and inspections. Your work will influence strategy, quality, and productivity in aseptic manufacturing. This is a chance to advance innovative solutions that enhance process capability and product quality within a collaborative, safety‑conscious environment.

Compensaciones / Incentivos
• Act as site SME for aseptic filling operations and isolator technology, providing technical leadership to Operations and cross-functional teams
• Lead investigations, deviations, CAPAs, change controls, risk assessments, and quality events to maintain quality standards
• Develop and continually improve manufacturing documentation, procedures, and technical standards to align with regulatory and business needs
• Define best practices for aseptic processing, CCS, and isolator technology, ensuring compliance with Annex 1 and industry expectations
• Support and lead manufacturing-related activities for new product introductions, tech transfers, equipment implementations, and facility projects
• Provide training on manufacturing processes, aseptic practices, and isolator technology to build capability across the organization




• Collaborate with suppliers and internal stakeholders to evaluate new technologies and equipment enhancements for aseptic manufacturing
• Maintain strong shop-floor presence, coaching operators and specialists and ensuring data-driven prioritization and decision making
• Support regulatory inspections and audits and act as a technical lead during troubleshooting of aseptic processes and critical systems
• Ensure safety, compliance with HSE requirements, and promote a proactive safety culture
• Represent Manufacturing in cross-functional teams for testing, commissioning, qualification, validation activities, and operational readiness
• Oversee documentation reviews and approvals to ensure accuracy and compliance
• Identify continuous improvement opportunities to improve robustness, efficiency, productivity, and product quality

Responsabilidades
• 6+ years in GMP pharmaceutical manufacturing
• Strong experience in aseptic manufacturing and advanced expertise in aseptic filling and isolator technology
• Experience leading deviations, CAPAs, change controls, and investigations
• Knowledge of FDA, EU GMP, and Annex 1 requirements
• Experience in process improvement and troubleshooting in manufacturing
• Ability to lead cross-functional initiatives and provide technical guidance
• Fluent English

Requisitos principales
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📌 Senior Manufacturing Specialist - Isolator Technology (León)
🏢 Trustack
📍 León