Jobs at Gerresheimer

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.

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 12,000 employees and generated annual revenues in 2023 of around EUR 2bn. 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.

Interested? Apply today!