Job Responsibilities
* Support and interface with process owners of systems and take part in daily activities upon request (provide technical and statistical support)
* Execute and document Equipment & Software validation
* Oversee validation and qualification activities executed by analysts, provide training and support
* Ensure cGMP compliant and timely implementation and maintenance of validated status of systems
* Conduct/participate in risk assessments, root cause analysis and investigations
* Identify, lead and drive improvements or change
* Provide technical assessments on protocols deviations and investigations
* Serve as SME for internal technical group discussions
Minimum Requirements
* Master’s in engineering, Computer Science, or related technical field
* Solid validation experience in the pharmaceutical industry
* Experience with validation life cycle requirements for cGMPs laboratory systems
* Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines
* A thorough knowledge of DI requirements and standard regulations for cGMPs operations
* Ability to identify and communicate risks in area of responsibility and across the site
* Fluency in English (C1) and French (C1)
Job Environment
* Long-term planned project
* Dynamic environment
* Continuous support during the assignment
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