Validation Engineer

Actalent; Schweiz; Vor Ort; CHF 90’000 - 130’000; Vollzeit

Zusammenfassung

A leading company is seeking a highly skilled Senior Validation Engineer for their team in Kaiseraugst, Switzerland. The ideal candidate will have over five years of experience in GMP environments and a strong understanding of regulatory requirements. Responsibilities include managing validations, ensuring compliance, and documenting GMP processes related to packaging and assembly systems. Candidates should be fluent in German and have a degree in a technical or scientific field.

Qualifikationen

• Minimum 5 years of GMP experience in qualification and validation, particularly in packaging systems.
• Strong expertise with regulatory inspections in packaging and assembly.
• Hands-on experience in validation of packaging processes.

Aufgaben

• Ensure GMP-compliant processes and documentation in packaging and assembly operations.
• Manage and process change notifications in Veeva.
• Create and maintain GMP-compliant documentation.

Kenntnisse

GMP quality systems

Regulatory compliance

Project management

Assembly processes

Fluency in German

Very good English skills

Ausbildung

Technical or scientific degree

Tools

Veeva systems

Digital validation tools

Jobbeschreibung

We are seeking a highly skilledSenior Validation Engineerto join our client's team inKaiseraugst. The ideal candidate would be someone with a strong background in GMP environments, particularly in the qualification and validation of packaging and assembly systems. The successful candidate will bring over five years of hands-on experience, a deep understanding of regulatory requirements, and a confident approach to inspections and compliance.

Responsibilities

As a Senior Validation Engineer, you will play a key role in ensuring GMP-compliant processes and documentation across packaging and assembly operations. Your main tasks will include:

• Managing and processing change notifications inVeeva
• Executingprocess validationsandfunctional tests
• Creating and maintainingGMP-compliant documentation
• Supporting validation activities for:
  • Primary packaging: Tablets and capsules in blisters and bottles
  • Secondary packaging: Vials, FSP, blisters, bottles in folding boxes
  • Assembly: Auto-injectors and needle safety devices (NSDs)

Must-Haves

To be successful in this role, you should meet the following criteria:

• Atechnical or scientific degreeor equivalent professional training
• Minimum 5 years of GMP experiencein qualification and validation, ideally in packaging systems
• Strong expertise inGMP quality systemsand efficient implementation of regulatory requirements
• Proven experience withregulatory inspectionsand compliance in packaging and assembly
• Hands-on experience with:
  • Assembly processes
  • Validation of packaging processes(solid filling in bottles, blisters, secondary/tertiary packaging)
• Strategic and conceptual thinking with solidproject and self-management skills
• Ateam-oriented mindsetwith a high degree of independence, structure, and initiative
• Fluent in German, with very good English skills

Nice to Haves:

• Experience withdigital validation tools(e.g., eVal, Kneat)
• Familiarity withVeeva systems

Additional information:

• Start Date: Immediately
• Contract Duration: Until June 30, 2026
• Location: Kaiseraugst

Job Title: Validation Engineer

Location: Kaiseraugst, Switzerland

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

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