Validation Engineer ( m/f/d)

Job Description

• Independent planning, coordination and implementation of necessary qualification and validation activities related to all production and support processes including corresponding documentation
• Validation activities during the projects including evaluation of test results and change/deviation management (e.g. for Production equipment, systems, software, peripherals, buildings and facilities etc.)
• Monitoring of the required quality activities around the Validation activities (e.g. ordering test equipment, material qualification, supplier matters)
• Creation of corresponding documentation according to the work instructions
• Support and, if necessary, organization of risk management activities within the projects
• Changes evaluation in terms of their impact on the qualified/validated state
• Carry out requalification activities
• Creation of customer declarations etc. (possibly in cooperation with others positions e.g. Regulatory Affairs)
• Create and maintain test/sample sets
• Support for internal audits, customer audits and if needed supplier audit
• Contribution to new procedures, procedure updates and improvements (process descriptions work instructions)

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.
• Knowledge of quality management, QM methods and QM guidelines
• Knowledge of IT applications (e.g. Office programs, MES, QM system)
• Very good knowledge of statistical QM methods
• 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
• Proficient user in English Language
• Willingness to international business travel within the first year of the employment as on boarding will be mainly in our facilities in Germany
• Employment will be with our company in the Republic of North Macedonia

Additional Information

All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.