7 дней назад
Head of Engineering & Maintenance - Lyophilisation (Biopharma)
84 000 - 112 000€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Head of Engineering & Maintenance - Lyophilisation (Biopharma): Leading engineering and maintenance activities for sterile filling and lyophilisation operations in pharmaceutical manufacturing with an accent on cGMP compliance, equipment reliability, and production continuity. Focus on implementing maintenance strategies, improving asset performance, managing shutdowns and budgets, and driving continuous improvement in a highly regulated environment.
Location: Waterford, Ireland; 5 days on-site
Salary: €84,000–€112,000 per year
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines for patients worldwide.
What you will do
- Lead engineering and maintenance activities for batch filling and lyophilisation operations.
- Ensure reliable supply, efficient batch turnaround, batch release, and equipment performance.
- Plan annual shutdowns, projects, programs, and continuous improvement initiatives.
- Maintain compliance with cGMP, FDA 21 CFR Part 211, EU GMP Annex 1, safety, and engineering standards.
- Deploy corrective, preventive, and predictive maintenance strategies and monitor maintenance KPIs.
- Manage maintenance budgets, headcount, parts, services, training, procedures, and GMP compliance.
Requirements
- Higher-level engineering degree or equivalent qualification.
- Significant experience as an Engineering and Maintenance Manager or in another management role.
- Experience in a pharmaceutical manufacturing environment and regulated operations.
- Technical knowledge of sterile filling and lyophilisation technology.
- Detailed knowledge of cGMP regulations, asset lifecycle management, health and safety, and legal requirements.
- Strong problem-solving, analytical, facilitation, interpersonal, and area-improvement skills.
Nice to have
- Engineering and maintenance expertise in sterile filling and lyophilisation.
- Engineering and maintenance management experience in pharmaceuticals.
- Experience working in a highly regulated industry.
Culture & Benefits
- Opportunity to contribute to medicine and vaccine delivery through advanced manufacturing technology.
- Work supporting global supply of life-changing treatments.
- Participation in an organization targeting more than 30 new product launches by 2030.
- Employee benefit programs may be available.
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