13 часов назад
Senior Engineer
70 408 - 95 259€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Engineer (Aseptic Drug Product Processing): Supporting commercial and new product manufacturing across European contract manufacturing sites with an accent on aseptic processing, process characterization, technology transfer, and process validation. Focus on troubleshooting formulation, filling, lyophilisation, inspection, and transportation processes while leading cross-site teams and resolving complex quality and manufacturing issues.
Location: Dun Laoghaire, County Dublin, Ireland, with international travel to contract manufacturing partner sites across Europe.
Salary: €70,408.90–€95,259.10 per year.
Company
operates in biotechnology and develops and manufactures therapeutic products, including biologics and other novel modalities.
What you will do
- Provide technical leadership and solutions for parenteral drug product manufacturing from drug substance thawing and formulation through filling, lyophilisation, inspection, and transportation.
- Support new product introductions, lifecycle changes, post-NPI activities, and ongoing commercial production across European contract manufacturing sites.
- Apply process development expertise in aseptic processing, process characterization, technology transfer, and process validation.
- Troubleshoot drug product processing technologies and equipment and identify operational improvements for sterile operations.
- Evaluate nonconformances and CAPAs with commercial manufacturing operations and external supplier quality teams.
- Lead cross-site collaboration and build relationships with contract manufacturers, Global Operations, supplier quality, and drug product process teams.
Requirements
- Bachelor’s degree in Science, Engineering, or a relevant Quality discipline with 5 years of similar experience; or a Master’s degree with 3 years of directly related experience; or an Associate’s degree with 10 years of directly related experience.
- Knowledge of cGMP requirements and worldwide regulatory standards.
- Experience supporting commercial protein drug product processing, including sterile processing, process characterization, technology transfer, or process validation.
- Strong engineering and scientific knowledge applied to freeze-thawing, filtration, mixing, filling, lyophilisation, and inspection processes.
- Excellent problem-solving, written communication, oral communication, and cross-functional leadership skills.
- A full clean driving licence is required to facilitate international travel.
Nice to have
- Italian or German language skills.
- Master’s or PhD in Science or Engineering.
- Knowledge of protein biochemistry, including chemical and physical stability.
- Project management experience, including managing multiple projects and evaluating resource requirements.
Culture & Benefits
- Work with a global Process Development organization and external manufacturing partners.
- Collaborate across Global Operations, supplier quality, and drug product process teams.
- Support a broad range of product formats, including cartridges, syringes, freeze-dried vials, and liquid vials.
- Work across diverse product types, including monoclonal antibodies, therapeutic proteins, small molecules, and novel modalities.
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