CSV Engineer

Proclinical Group; Boudry; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

A prominent recruitment agency is seeking skilled engineers for a temporary contract in Boudry, Switzerland. This role focuses on Computer System Validation (CSV) within the Life Science industry, requiring strong regulatory knowledge and proactive collaboration. Candidates will contribute significantly to ongoing projects and compliance efforts while enjoying opportunities for personal and professional growth in a dynamic work environment.

Qualifikationen

• Proven years of working experience in Computer System Validation (CSV).
• Strong knowledge with current international regulatory regulations, including 21 CFR part 11, EU-GMP guidelines.
• Good level of English; French preferred.

Aufgaben

• Develop and justify the CSV approach based on risk and scientific rationale.
• Ensure equipment and systems are qualified and validated in compliance with regulations.
• Participate in internal and external audits as SME.

Kenntnisse

Collaboration

Problem Identification

Data Integrity

Ausbildung

BS/MS in Engineering/Technical discipline

BS/MS in IT (Hardware and Software)

Tools

Manufacturing Execution System (MES)

Jobbeschreibung

Are you ready for a change? Tired of the same routine? Join our client's team and make your mark in the industry!
Have a look below and apply or send me your CV directly.

Proclinical is recruiting for 3 dedicated and skilled engineers for a temporary contract position of 9-months which is based in Boudry, Switzerland

Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Key responsibilities:

• Develop and justify the CSV approach based on risk and scientific rational
• Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle
• Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports.
• Execute CSV activities and manages people with the role of tester (including vendors) for all equipment and systems across the site, including QC, warehouse, facilities, lab equipment, utilities and computer system validation, excluding global IT systems.
• Define and execute periodic activities maintaining qualified/Validated states of equipment, analytical instruments, utilities & facilities and computerized system
• Contributes to the development and maintenance of the local site procedures
• Ensure the CSV strategy on site fit with global CSV strategy in collaboration with global team
• Lead risk assessments and risk management teams
• Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
• Co-ordinate CSV execution activities, including external vendors and internal departments.
• Supervision of internal and external resources dedicated for project.
• Leads new hire process for additional CSV activities
• Participate in internal and external audits as SME, by answering questions, reviewing CSV with auditors, and providing documentation.
• Establish and maintain effective relationships with internal team, customers and suppliers.
• Contributes to continuous improvement, including proactively identifying problems and proposing solutions
• Autonomous; completes work independently, seeking guidance on complex tasks and on non-routine decisions
• Participates in projects and initiatives as directed by their leader

Requirements:

• BS/MS in Engineering/Technical discipline or equivalent experience or BS/MS in IT (Hardware and Software)
• Proven years of working experience in CSV
• Strong knowledge with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
• Good ALCOA & Data Integrity knowledge
• Strong knowledge on IT systems especially MES (Manufacturing Execution System) and interfaces with other systems (process equipment, ERP, LIMS…)
• Knowledge of Oral Solid Dosage bulk pharmaceutical process is a plus
• Communicates pro-actively and collaboratively
• Proactively identifies problems and recommends solutions Team player: ability to interact effectively with team and customers
• Good level of English
• Ability to communicate in French is preferred

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at [e-mail] or [phone]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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