Validation Expert (M/F)

Job description

Validation Expert (M/F)

Your role :

The BioMonitoring Research and Development organization develops new products and equipment for our microbiology laboratories customers in the pharmaceutical and food industry. You are an important contributor in the development project teams, in charge of ensuring the validation of our solutions in accordance with the requirements of our customers: GMP, GAMP, ICH guides, ISO standards.

In the project team, you lead upstream risk assessment on specifications and support functional risk analysis. You define the product validation strategy during its development and commissioning, to guarantee its quality and compliance with regulations and specifications. You write the VMP. You organize and document the validation work. To this end, you help to define plans and methods to characterize, verify and validate the performance of the equipment, based on risk analysis. You develop guides and validation plans for the end user to allow our field validation teams to carry out QIQOs at the customer's site.

You contribute to the implementation of product quality documentation, in collaboration with production and subcontractors.

In the R&D validation team, you contribute to regulatory monitoring and continuous improvement of validation practices and tools.

 

Who you are :

·  License, master or engineer in a scientific or technical field
·  5 years of experience in the pharmaceutical industrial environment, in validation activities (FAT, SAT, IQ OQ PQ) on ideally automated processes.
·  Experienced working in project mode, ideally in a complex and multidisciplinary technical activity.
·  Autonomous, rigorous, organized and good communication skills. As a member of an R&D organization, you are curious and eager to bring innovative solutions to our customers.
·  Good level of English, written and oral. Ability to work in a multicultural organization.
·  Quality Knowledge: risk analysis methodologies, experience of Good Manufacturing Practices ideally in aseptic production, first experience of GAMP. Statistical analysis of the data (capability, design of experiment, ANOVA)

Job Requisition ID: 208658

Location: Molsheim

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

Working time model: full-time, part-time possible

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.

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