Validation Engineer Opportunity
This role is ideal for individuals with a strong background in validation and a passion for ensuring the highest standards of quality and compliance in a dynamic manufacturing environment.
About the Role:
The Validation Engineer will be responsible for executing FAT/SAT/IOQ protocols, designing and executing validation studies, and ensuring that all validation activities are managed in accordance with relevant Sanofi standards and legal requirements.
Key Responsibilities:
* Executing FAT/SAT/IOQ protocols, including protocol generation and reporting.
* Designing and executing validation studies for equipment, systems, and processes.
* Maintaining validation documentation throughout the validation lifecycle.
* Providing technical interpretation and guidance on current US FDA and EU validation requirements.
* Ensuring that the validation status of equipment and systems meets cGMP requirements at all times.
Requirements:
* Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
* 3-5 years' experience working in a healthcare manufacturing environment, ideally in the pharmaceutical sector.
* Natural influencer and team player with excellent communication skills.
* Highly motivated and self-resilient individual with a can-do attitude.
* Adaptable and flexible problem solver with a pragmatic approach.
Benefits:
This role offers a unique opportunity to work in a collaborative and inclusive environment, with a focus on delivering high-quality results and contributing to the success of the organization.
Others:
This position requires a strong understanding of quality management systems, process validation regulations, and technical transfer industry practices. The ideal candidate will have excellent technical knowledge of pharmaceutical plants, previous validation/product development experience, and knowledge of GAMP, ISPE Baseline guides, and steam/dry heat validation publications.
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