- 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)
- 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.
- 1-2 years of experience using project management methods
- 1-2 years of using statistical QM methods
- 1-2 years of experience working with IT applications (e.g. Office programs, MES, QM system)
- Knowledge of quality management, QM methods and QM guidelines
- Knowledge of problem-solving methods (e.g. KT)
- Good technical understanding in dealing with specifications
- Excellent analytical competence (especially in the field of interpretation of results and derivation of further measures)
- Fluent in English
- Mon - Fri / 40hrs
- company health benefits, 401k, incentive bonuses
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Validation Engineer - Peachtree City, United States - Gerresheimer
Description
Company DescriptionGerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.
Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 87,500 sq. ft. production facility with 200 employees.
Job Description
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