Validation Engineer (m/f/d)

  • Full-time

Company Description

Gerresheimer is a leading global partner to the pharma and healthcare industry. Since its foundation in Germany in 1864, the publicly traded company now operates worldwide with 10,000 employees and generates revenue of €1,4 billion. Gerresheimer’s product portfolio includes pharmaceutical packaging and products for the safe and simple administration of medicines, i.e. insulin pens, inhalers, pre-fillable syringes, injection vials, with manufacturing facilities in Asia, Europe and North-and South America.
Gerresheimer will build and establish a new facility in Skopje, North Macedonia as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry.

Job Description

  • Independent assurance of the standardized implementation and documentation of validations to guarantee the necessary product quality
  • Independent creation of validation plans with all necessary individual tasks and independent monitoring of the implementation of the final release within the framework of life cycle management for:

    • Injection molding machines

    • Tools

    • Assembly systems

    • decentralized periphery (e.g. tempering devices)

    • Buildings/clean rooms

    • comprehensive equipment (high-bay warehouse, compressed air, material preparation, etc.)

    • Software

  • Independent support of the internal interfaces within the scope of the task and initiation of any necessary escalations.

  • Support of the quality organization by independent assumption and execution of projects or subprojects

  • Independent supervision of external validations

  • Continuous improvement / 5S

  • Independent compliance with standards and legal regulations as well as occupational safety and hygiene regulations

Qualifications

  • Knowledge as typically acquired during at least 3 years of technical university studies (e.g. mechanical engineering, industrial engineering, or similar) and extended by at least 5 years of relevant professional experience in the areas of quality assurance, qualification and/or validation. This function requires special knowledge in the areas of verification and validation of processes & qualification of equipment.
  • Expert knowledge of quality management and QM methods
  • Expert knowledge of the relevant QM guidelines
  • Knowledge of IT applications (e.g. Office programs, MES, QM system)
  • Very good knowledge of statistical QM methods
  • Very good IT knowledge (e.g. MS Office, Hydra/Guardus, SAP QIM)
  • Knowledge of problem-solving methods (e.g. KT)
  • Good technical understanding in dealing with specifications
  • User knowledge of project management methods
  • Excellent analytical competence (especially in the field of interpretation of results and derivation of further measures)
  • Structured working method

 

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