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Gerresheimer

Global supplier of pharma packaging solutions

Validation Engineer

Validation, Compliance & Quality SystemsPosted on Nov 10
Full-timeMK, North MacedoniaNo salary listedIn-person

About the Job

Requirements

  • A completed technical university degree, requiring a minimum of three years of academic education.
  • At least five years of relevant professional experience in quality assurance, qualification, and/or validation.
  • Specialized knowledge and practical experience in verification and validation processes.
  • Good command of information technology applications, including Microsoft Office, Manufacturing Execution Systems, and Quality Management Systems.
  • Knowledge of structured problem-solving methodologies, such as KT.
  • Strong technical understanding and the ability to work with technical specifications.
  • Familiarity with project management methodologies and tools.
  • A structured, systematic, and detail-oriented approach to work.
  • Good command of written and spoken English.

Responsibilities

  • Independently plan, coordinate, and execute qualification and requalification activities, as well as validation activities within projects, including evaluating test results, changes, and deviations.
  • Monitor and ensure the implementation of quality-related activities associated with qualification and validation processes.
  • Prepare and maintain relevant documentation in English in accordance with applicable standards, guidelines, and regulatory requirements.
  • Support and coordinate risk management activities within projects and processes where necessary.
  • Assess changes and their potential impact on the qualified and validated status of test methods, processes, systems, and equipment.
  • Prepare customer declarations and related documentation, and communicate with customers when necessary.
  • Create, maintain, and update test and sample sets.
  • Provide support during internal, external, and supplier audits.
  • Independently develop, revise, and improve relevant operational procedures, work instructions, and forms.
  • Drive continuous improvement initiatives within the area of responsibility.
  • Manage documentation and apply good documentation practice.

Desired Qualifications

  • German language skills are considered an advantage.
  • Preparing and maintaining relevant documentation in German is considered an advantage.

About the Company

Gerresheimer

Global supplier of pharma packaging solutions

Gerresheimer creates specialized packaging and drug delivery devices for the pharmaceutical and biotech industries. Its offerings include packaging solutions and device components for medicines, such as inhalers and insulin pens, as well as complex drug delivery systems. The company works by designing, engineering, and manufacturing these components to meet strict pharma quality and regulatory standards, serving as a global partner to pharma and biotech customers. It differentiates itself by shifting from consumer glass products to focused, high-spec packaging and device solutions for pharma and cosmetics, building its business around close collaboration with customers and end-to-end support. The goal is to help pharmaceutical and biotech companies bring safe, reliable, and scalable packaging and delivery technologies to market across the globe.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Düsseldorf, Germany
Founded
1864

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