Validation Engineer
650 Highway 74 South, United States | Peachtree City | Full-time
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.
- 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
Additional Information
- Mon - Fri / 40hrs
- company health benefits, 401k, incentive bonuses
All your information will be kept confidential according to EEO guidelines.
Benefits
Food & drinks
We have a self -serve break area with drinks, snacks & light finger food for purchase.
Learning & development
According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities. We offer education reimbursement.
Healthcare & pension
Your health and well-being is important to us. We offer the following benefits: 401 K Match up to 4.5%, Medical/ RX/ Dental/ Vision, Life LTD & STD, Optional Accidental / Critical Care and Illness & Hospitalization, Optional Spouse & Child
Working environment
Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).
Wellness & other incentives
Referral program, Gym incentive, Pacer step challenge
Note: Benefits might vary depending on the position.
