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