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Validation Engineer - Peachtree City, United States - Gerresheimer Ag
Description
650 Highway 74 South, United States | Peachtree City | Full-timeJob 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 theprojects
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)
Additional Information
Mon - Fri / 40hrs
company health benefits, 401k, incentive bonuses
All your information will be kept confidential according to EEO guidelines.
We have a self -serve break area with drinks, snacks & light finger food for purchase.
According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities.
We offer education reimbursement.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 incentivesNote:
Benefits might vary depending on the position.
About Gerresheimer Gerresheimer 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.About Gerresheimer Gerresheimer 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.Equal rights We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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.Equal rights We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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.#J-18808-Ljbffr