Equipment CQV Specialist
Equipment CQV Specialist
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Job Description
Production
About the Job
As 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:
Connect with us onLinkedIn
Required Experience:
Unclear Seniority
Employment Type
Full-Time
