Bachelor's degree in mechanical engineering, chemical engineering, computer science, or related fields relevant to biotech or pharmaceuticals.
3+ years of experience in a Validation organization within pharmaceuticals, biologics, or medical devices.
3+ years of experience with facility startups, factory/site acceptance testing, and Commissioning/Qualification activities.
Experience in continuous improvement of Validation operations in response to audits and inspections.
Proficient in executing validation protocols, project plans, and data analysis.
Familiarity with asset management and NIST traceability to standards.
Demonstrated compliance with US, EU, and ICH GMP requirements.
Responsibilities
Support cross-functional teams in achieving validation lifecycle deliverables.
Provide QA oversight for GMP validation activities using risk-based methodologies.
Assist in developing project plans and validation deliverables for field activities.
Enforce compliance with validation strategies and internal standards.
Author and maintain Standard Operating Procedures for GMP validation.
Support phase-appropriate validation strategies for new and existing facilities.
Conduct QA assessments and approvals for validated systems and related procedures.
Benefits
Collaborate with a supportive, future-focused team in groundbreaking research.
Access to career growth opportunities, including promotions and international moves.
Engage in innovative AI-driven research and smart manufacturing.
Contribute to global vaccination efforts impacting half a billion people annually.
Receive mentoring and international mobility program access.
Enjoy a comprehensive rewards package recognizing your contributions.
Benefit from extensive health and wellbeing programs, including high-quality healthcare and generous parental leave.
Full Job Description
Job title: Quality Assurance Validation Engineer
Location:Waltham, MA
About the Opportunity
The QAV Engineer will support both the Business System Owners and cross-functional technical departments (Validation, Metrology and Automation) at Sanofi's mRNA Center of Excellent (CoE) and will report to the Deputy Director, Quality Assurance Validation. This individual will be responsible for supporting all field activities supporting internal and external QA Validation efforts as it pertains to Sanofi's mRNA Center of Excellence - at its various internal facilities and CMO's. This individual will be responsible for supporting a team of FTE's and consultants for Validation and Computer Systems Validation efforts at or on behalf of Sanofi's mRNA CoE, for QAV related activities.
Main Responsibilities
Key responsibilities
Support and work in partnership with Validation, Automation, Metrology and Quality Control department personnel as well as cross-functionally with sub-QA departments to achieve deliverable and all routine Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment and build strong working relationships.
Provide QA oversight for GMP validation activities and apply risk-based methodology to validation efforts to help drive deliverables on time in a compliant manner, while serving as the QA Validation Subject Matter Expert and interacting with Business System Owners on their needs.
QAV support on the necessary Project Plans, end to end Validation deliverables and supports any field activities performed in support of their execution.
Help enforce compliance with senior leadership strategy and direction, as it pertains to the areas of equipment validation, computer systems validation, cleaning validation, Data Integrity initiatives and routine maintenance of validated systems.
Help author and maintain Standard Operating Procedures incompliant with internal/global standards to support Equipment and Computer System validation for GMP.
Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs.
Provide QA assessment and approval of GMP validated systems related procedures, deviations, CAPAs and change controls with no supervision depending on complexity of system.
Provide support for additional QAV-related activities during internal audits and self-inspections, supporting documentation, investigations and remediation activities as required.
Support Sanofi's mRNA CoE Metrology and Automation department:
Act as the QA contact and QA subject matter expert (SME) on the Metrology and Automation of all equipment/instruments partnering with technical departments and Business System Owners to ensure Data Integrity and cGMP compliance.
Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs.
Help investigate and support management in all investigations stemming from Equipment/System 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.
Be accountable for:
Implementing the process and tool at local level in line with the standardized and harmonized approach, including communication, change management, etc as appropriate.
Be responsible for:
Being the "Voice of Customer"
Providing feedback on the roadblocks and difficulties met related to Sanofi Community of Practice (CoP) area supported
Providing return on experience on inspection assessing the CoP area supported Proposing evolution for simplification and harmonization of the process and tool
Sharing successes and best practices with other sites
Contributing to the objectives set via the CoP roadmap
About you
Bachelor's degree in mechanical engineering, chemical engineering, computer science, or related fields relevant to the biotech or pharmaceutical industry.
Minimum 3+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries.
Minimum 3+ years of experience working with facility startups, 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.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.
Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.
Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
The salary range for this position is: $78,000.00 - $112,666.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
About Sanofi
Sanofi is a global pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs and vaccines. The company operates in over 170 countries and has a diverse portfolio of products that includes treatments for diabetes, cancer, cardiovascular disease, and rare diseases. Sanofi is committed to improving global health and has a strong focus on innovation and sustainability. The company has received numerous awards for its research and development efforts and is recognized as a leader in the pharmaceutical industry.
