QA Validation Engineer (all genders)

Job description

QA Validation Engineer (all genders)

Your role:

You will be responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, computerized systems. In this role you will assist individuals on a site level as well as write computerized systems validation guidance documents on a Life Science scope. You will provide expert guidance on all aspects of validation and will need to travel to directly assist individuals/site requiring specific support for a limited time during regulatory inspections and/or large projects. You will review and become an expert in the regulatory guidelines as well as being current on potential changes which may impact the validation requirements. You will also provide expert guidance during regulatory audits and will provide project management support for projects which don't have site specific support systems in place. The role of QA Validation Engineer is to provide validation and quality assurance support for computerized systems, digital products, Process Controls systems, software systems, and IT infrastructure that have been newly developed, installed, upgraded, replaced and / or modified for the use in cGMP area.

 

Who you are:

·  Bachelor’s degree in chemical, computer science, bio medical, engineering or another life science discipline
·  7+ years of relevant experience in validation, handling of multiple projects and quality assurance
·  Good written and verbal skills in English.
·  Excellent computer skills, i.e., Project Planning, Word, Excel, PowerPoint, SharePoint
·  Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
·  Travel Requirements: Global travel required based on the need of project and business

Job Requisition ID: 207274

Location: Darmstadt

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Developer, Medical, Quality Assurance, QA, Computer Science, Technology, Healthcare, Quality