Quality Assurance Validation Engineer

BioSpace; Waltham (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Sanofi in Waltham, MA is seeking a Quality Assurance Validation Engineer to support GMP validation for facilities, utilities, systems and equipment. You will work with Validation, Metrology and Automation teams to ensure data integrity and regulatory compliance.

Required is a Bachelor's in engineering or related field and 3+ years in a validation role within pharma/biotech, with hands-on experience in equipment and computer systems validation and regulatory documentation.

Qualifications

• Excellent oral and written communication skills.
• Strong interpersonal and collaboration abilities.
• Experience with validation activities in pharma/biotech.
• Knowledge of cGMP/compliance concepts.

Responsibilities

• Provide QA oversight for GMP validation activities and apply risk-based methods to drive timely deliverables.
• Support validation lifecycle for facilities, utilities, systems and equipment; act as SME.
• Author and maintain compliant validation documentation and SOPs.
• Assist with investigations, CAPAs, deviations, and change controls during audits.

Education

Bachelor's degree in mechanical engineering, chemical engineering, computer science, or related fields

Job description

Job title:Quality Assurance Validation Engineer

Location: Waltham, MA

About The Job

In the race for the future of health The Sanofi mRNA Center of Excellence (CoE)

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.

Thats why were looking for bold, optimistic world-changers to join our mRNA Center of Excellence. Were 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!

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, youll help advance prevention on a global scale - and shape the future of immunization.

About The Opportunity

The QAV Engineer will support both the Business System Owners and cross-functional technical departments (Validation, Metrology and Automation) at Sanofis 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 Sanofis mRNA Center of Excellence - at its various internal facilities and CMOs. This individual will be responsible for supporting a team of FTEs and consultants for Validation and Computer Systems Validation efforts at or on behalf of Sanofis mRNA CoE, for QAV related activities.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

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 Sanofis 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 Sanofis mRNA CoE documentation.

Ensure that Sanofis 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

Bachelors 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 its 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.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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 vaccinatedagainst COVID-19 as part of your job responsibilities.

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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.