Validation Engineer - Xecutive Recruitment Inc
Peachtree City, GA 30269
About the Job
Validation Engineer - $60k-90k/MAX – no bonus structure
There are 2 positions and has 2 interview but nobody else .
There are 2 positions and has 2 interview but nobody else .
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 maiin 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
Source : Xecutive Recruitment Inc