Descripción de la oferta
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 / Beneficios
• 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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