23 часа назад
Manufacturing Manager
78 613 - 106 359€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Manager (Aseptic Drug-Product Manufacturing): Leading manufacturing support for formulation and aseptic filling operations with an accent on process ownership, GMP compliance, quality systems, and operational readiness. Focus on managing technical transfers, process validation, contamination control, investigations, and continuous improvement across complex cross-functional initiatives.
Location: Dublin, Ireland; hybrid role requiring onsite presence three days per week
Salary: €78,613.10–€106,358.90 per year
Company
develops and manufactures biopharmaceutical products.
What you will do
- Lead the Aseptic & Process Owner team supporting formulation and aseptic filling operations, including ADL2.
- Maintain manufacturing processes in a validated, controlled, compliant, and inspection-ready state throughout the product lifecycle.
- Monitor process, operational, and quality data; identify trends and risks; and lead corrective actions.
- Provide technical leadership for aseptic operations, technology transfers, process validation, engineering studies, and process changes.
- Oversee deviations, investigations, CAPAs, change controls, and effectiveness verifications.
- Partner with Manufacturing, Quality, Engineering, Process Development, Supply Chain, and other site functions to deliver projects and resolve complex issues.
Requirements
- Bachelor’s degree in Engineering, Science, or a related discipline.
- Minimum five years of experience in aseptic drug-product manufacturing operations, preferably syringe or vial filling.
- Strong knowledge of GMP and applicable GxP requirements.
- Experience with aseptic processing, process ownership, manufacturing support, technical transfer, validation, or lifecycle management.
- Experience leading cross-functional teams and managing multiple complex projects.
- Experience with quality systems, contamination-control strategies, aseptic process simulations, investigations, CAPAs, and change controls.
Culture & Benefits
- Leadership role focused on safety, quality, compliance, and operational performance.
- Responsibility for coaching, team development, succession planning, and capability building.
- Collaboration across multiple technical and site functions.
- Support for corporate, FDA, HPRA, and other regulatory inspections and audits.
- Hybrid working arrangement with three onsite days per week.
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