Sanofi Group Validation Specialist - VIE Contract (W/M) in Waltham, Massachusetts
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.
Therefore, only applications that are submitted in English will be considered.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.
We are looking for: Validation Specialist - VIE Contract (W/M)
Target start date: 01/07/2023
The Validation VIE will support both the Validation and Metrology departments at Sanofi’s mRNA Center of Excellence (CEW) and will report to the Quality Assurance Validation Manager. This individual will be responsible for supporting all field activities supporting internal and external Validation efforts as it pertains to Sanofi‘s mRNA Center of Excellence - at its various internal facilities, CMO’s (Contract manufacturing organization (https://en.wikipedia.org/wiki/Contract_manufacturing_organization) ) and Cleanrooms on Demand. This individual will be responsible for supporting a team of FTE’s (full-time equivalent), and consultants for both the Validation and Computer Systems Validation efforts at or on behalf of Sanofi’s mRNA CoE (Centre of Excellence), as well as supporting the Metrology department is asset management and calibration activities.
Support Validation projects for new equipment (Manufacturing and Analytical) for the Phase I, II and III activities
Support in generating/ revising documentation (commissioning and qualification protocols) to support CQV (Commissioning, Qualification and Validation) project initiatives
Assist Validation team members with validation activities during the tech transfer of new process in the facility
Assist with CQV revalidation program for the site
Build partnerships with other department team members at the sites
Promote validation standard methodologies and ensures compliance with Sanofi SOP’s (Standard Operational Procedures), and cGMP(Good Manufacturing Practice) regulations
The position involves close collaboration with Manufacturing, Analytical Sciences, Quality Assurance, Information Systems, and other Engineering teams to finish the responsibilities
Build partnerships with cross-functional teams for technical and non-technical work
Archival of validation documentation following company record retention procedures
Support the Maintenance and calibration activities of validation equipment (to be performed by outside vendor)
Perform other Validation and Metrology related duties as assigned
Master’s Degree in Chemical/ Computer Science/ Electrical/ Mechanical Engineering, Biotechnology or Pharmaceutical
At least 1 year of professional experience relevant to biotechnology or pharmaceutical industry
Interest and/or experience with performing Manufacturing and Analytical equipment qualification activities
Customer-focused attitude, with high level of professionalism and discretion
Ability to be proactive in communication with all levels within the organization
Understanding of problem-solving steps and processes to apply in a real-world situation
Detail-oriented, resourceful, and diligent
Must be proficient in English both verbal and written
Strong computer software skills (e.g., Excel, Word)
Cumulative 3.0/4.0 GPA or higher
Languages : English
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.