Quality Assurance Validation Engineer I

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before. 

That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.   

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology! 

About the Opportunity

The Validation Specialist will support both the Validation and Metrology departments at Sanofi’s mRNA Center of Excellent (CoE) and will report to the 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 and Cleanrooms on Demand.  This individual will be responsible for supporting a team of FTE’s and consultants for both the Validation and Computer Systems Validation efforts at or on behalf of Sanofi’s mRNA CoE, as well as supporting the Metrology department is asset management and calibration activities.

Support Sanofi’s mRNA CoE Validation department

• Field support of the FTE and consultant activities in the Commissioning, Validation and Maintenance phases of the Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment.

• Author the necessary Validation Protocols and Project Plans, and support all field activities performed in support of their execution.

• Help drive on time deliverables in a compliant manner, while serving as the Validation Subject Matter Expert and interacting with customers on their needs.

• Serve as liaison and cross-functional lead with Engineering, Manufacturing and Quality Assurance to provide an overall compliant program with industry standards and GMP regulations.

• Help review proposed changes to validated systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change.

• Help enforce compliance to senior leadership strategy and direction, as it pertains to the areas of cleaning validation, equipment validation, computer systems validation and routine maintenance of validated systems.

• Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs.

• Provides QAV support to the validation team during document review to ensure the organization is complying with local and global quality standards and regulatory requirements.

• Reviews and approves master plans, pre/post approval of qualification and validation protocols, Validation discrepancies, supports investigations and corrective actions, summary reports, associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

• Serve as the QAV for lab and process equipment qualification, and Metrology/ Calibration/ Maintenance to ensure it remains in a state of control.

• Maintain Equipment and CSV master list and manage and carry out Requalification and periodic reviews.

Support Sanofi’s mRNA CoE Metrology department

• Support the site-wide calibration and maintenance program for all Sanofi mRNA CoE owned GxP equipment and systems.

• Support the planning, scheduling and completion of all Metrology work performed to ensure timely maintenance and calibration activities on Sanofi’s mRNA CoE owned equipment and systems.

• Help investigate and support management in all investigations stemming from instrument failure and determines best course of action for resolution

Promote a Quality Culture

• Support innovation, teamwork and a continuous improvement effort in the level of Quality in Sanofi’s mRNA CoE documentation.

• Ensure that Sanofi’s mRNA CoE Validation documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.

• Bachelor’s (or post-graduate degree) in a relevant field to the biotech or pharmaceutical industry.

• Must have 3+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries.

• Must have 3+ years of experience in working with facility start ups, factory/site acceptance testing, Commissioning/Qualification activities and all associated supporting documentation generated during the course of these activities.

• Experience with continuous improvement of Validation operations in response to business needs and customer audits/regulatory inspections.

• Experience in execution of field activities associated with validation protocols, project plans, data analysis, compilation of data into final reports and project summary/close out.

• Experience in asset management and in NIST traceability to standards.

• Demonstrated experience in working in compliance with US, EU and ICH GMP requirements.

• Preferable experience in early phase clinical efforts, which are not under the stringent requirements of a commercial facility.

• Preferable experience in supporting a Phase I/II company up through commercialization.

• Excellent oral and written communication skills.

• Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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