6 дней назад
Senior Engineer - Process & Equipment (Biopharmaceutical Manufacturing)
70 408 - 95 259€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Engineer - Process & Equipment (Biopharmaceutical Manufacturing): Supporting commercial aseptic drug product filling and ensuring the reliability and lifecycle management of manufacturing equipment with an accent on GMP operations, equipment performance, and continuous improvement. Focus on leading root cause analysis, managing complex engineering projects, coordinating maintenance and spare parts, and introducing new products and technologies.
Location: Ireland - Dublin; onsite at Dun Laoghaire
Salary: €70,408.90–€95,259.10 per year
Company
operates a 37,000-square-metre aseptic drug product facility specializing in formulation, vial and syringe filling, lyophilisation, and packaging.
What you will do
- Own drug product manufacturing equipment and systems in a GMP-regulated environment.
- Monitor equipment performance, analyze trends, and proactively manage reliability risks.
- Lead system improvements, technical specifications, engineering documentation, and standard operating procedures.
- Conduct root cause analyses, incident investigations, after-action reviews, and complex problem-solving activities.
- Manage change controls, equipment lifecycle activities, new product or technology introductions, and engineering runs.
- Plan preventive maintenance, vendor support, major overhauls, and spare-parts inventories to minimize downtime.
Requirements
- Bachelor's degree in Mechanical, Manufacturing, Mechatronics, Electrical, Chemical, or another relevant engineering discipline.
- Manufacturing experience in a regulated environment.
- Experience with statistical analysis tools and continuous improvement methodologies.
- Applied engineering and problem-solving skills relating to mechanical, electromechanical, and automation systems.
- Ability to collaborate cross-functionally and communicate engineering activities clearly.
- Travel may be required at various times to support project execution.
Nice to have
- Experience in biopharmaceutical formulation, fill-finish, or API facilities.
- Direct experience with vial or syringe filling equipment.
- Experience with change control, non-conformance, CAPA, and validation practices.
- Experience with new product introductions, new technology deployment, vendor management, and contract negotiations.
- Experience developing and presenting project plans to senior management.
Culture & Benefits
- Collaborative, team-based work environment with cross-functional decision-making.
- Competitive benefits and a comprehensive total rewards plan aligned with local industry standards.
- Support for professional growth, personal well-being, and workplace accommodations.
- Inclusive and ethical environment focused on advancing science and improving patient care.
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