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Lonza

Global life sciences contract manufacturer

Qualification and Validation Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeVisp, SwitzerlandNo salary listed

About the Job

Requirements

  • Completed education at ETH, FH, or HF level, or comparable professional experience.
  • Good professional experience in a regulated environment with commissioning, qualification, and validation, for example of refrigerators and freezers, clean utility rooms, or process equipment, is an advantage.
  • Good knowledge of Microsoft Office is required; knowledge of COMOS, DMS, TrackWise, and SAP is advantageous.
  • Fluent spoken and written German and business-fluent English.
  • Ability to work independently and flexibly, with a structured, focused, and well-organized approach.

Responsibilities

  • Plan, coordinate, and execute initial qualifications and requalifications of facilities, systems, and technical equipment throughout their lifecycle.
  • Assess technical changes for qualification impact and ensure the qualified state of existing facilities and systems.
  • Create, process, and coordinate Technical Change Requests (TCRs), and support deviations, investigations, and CAPA measures.
  • Create, review, and maintain CQV-, engineering-, and GMP-related documentation in compliance with applicable GxP requirements.
  • Serve as a subject matter expert for CQV topics and advise engineering, operations, quality assurance, and project teams.
  • Support and represent the function during internal and external audits, inspections, and customer visits.
  • Conduct periodic reviews, support decommissioning activities, and ensure ongoing compliance requirements are met during facility operations.
  • Contribute to the ongoing optimization of processes, facilities, and internal workflows.
  • Help maintain the required technical knowledge of plant personnel and engineering groups.

Desired Qualifications

  • Good professional experience in a regulated environment with commissioning, qualification, and validation, for example of refrigerators and freezers, clean utility rooms, or process equipment.
  • Knowledge of COMOS, DMS, TrackWise, and SAP.

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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