Equipment CQV Specialist

Tytuł pracy:

Equipment CQV Specialist

Firma

Xellia Pharmaceuticals

Opis stanowiska

Equipment CQV Specialist
ProductionAbout the JobAs an Equipment CQV Specialist, you will serve as a member of the Manufacturing Science and Technology team at our Budapest site, supporting the standardization and qualification of critical equipment across all aseptic production sites and activities. You will play a vital role in equipment lifecycle management, validation documentation review, and implementation of global standards to ensure compliance, efficiency, and readiness for regulatory inspections.Main Responsibilities

• Collect all practices across aseptic production plants and support delivering corporate standards for qualification of equipment (per critical equipment: tunnels, filling machines, autoclaves, HVAC, utilities)
• Review of individual Equipment Qualification Protocol/Reports
• Participant in the creation of one single database for aseptic equipment/areas and structured according to the function and criticality
• Review/Support of preparing Validation Master plans
• Developing procedure for Equipment life cycle (Equipment card, CC, URS, Functional specification etc.)
• Ordering of equipment
• Improving on knowledge on regard to the new technologies
• Upgrades of existing equipment to deliver higher yields for relevant processes/reduce costs
• Writing of global standards (Corporate standard – Manufacture) or to have minimum information for URSs when new equipment is ordered
• Assist in regulatory/quality issues (inspections, audits, filings)
• Report results according to department and project plans
• Adhere to company policy e.g. purchasing, travel, EHS etc.
• Act according to the Xellia behavior standards at any point in time

What We Expect

• Degree in Mechanical or Chemical Engineering
• Min. 5 years relevant experience in the aseptic pharmaceutical industry – particularly in equipment qualification, validation, or manufacturing support within GMP-regulated environments
• Fluent in English (spoken and written)
• Handle multiple tasks in a fast-paced environment
• Proactive and empathetic personality

What We Offer

• Competitive compensation and benefit package
• „Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment
• Home office opportunity

Xellia Pharmaceuticals is a specialty pharmaceutical company and a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive heritage in developing, manufacturing, and commercializing anti-infective products.Headquartered in Copenhagen, Denmark, and owned by Novo Holdings A/S, Xellia Pharmaceuticals has more than 1400 employees globally, including state-of-the-art manufacturing sites in China, Denmark, and Hungary. Our strong market position is built on more than 120 years of pharmaceutical industry experience.Further information about Xellia can be found at:
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Data pracy

Sun, 18 May 2025 01:36:26 GMT

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