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A Range of Possibilities

Validation Manager - Vaccines - hybrid

date posted 05/27/2022
contract type Full time
job id R2633857
location Swiftwater, Pennsylvania

For this role, Sanofi flexible work guidelines supports, on average, 2 days a week remote working location with the balance spent at the designated site.

Sanofi Pasteur is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. This role supports the US vaccine manufacturing sites located in Swiftwater, PA, and Pearl River, NY. The primary location is Swiftwater, located in northeast Pennsylvania and is home to the production of over 140 million doses of vaccine each year. 

Manufacturing Technology (MTech) drives the vaccines industrialization and the improvement of processes and products. It embarks on new technologies and digital trends and is the keeper of manufacturing process knowledge. MTech is at the crossroads of R&D and production as the team is spread over 9 production sites.

Close collaboration with R&D to ensure that the processes for new vaccines are as innovative and standardized as possible to guarantee efficacy, cost-effectiveness, and rapid time to market quality vaccines. It is a multi-disciplinary function that provides expertise in the process; manufacturing sciences, process modeling, statistical analysis; process validation, and technology transfer. Commitment and solidarity are key in the MTech department. The Global MTech organization is the seeding ground for technical and scientific talents that execute their work in a large network and offer multiple possible career evolutions. You will be integrated into a team where you will acquire scientific and technical skills, alongside our experts, our data scientists, our project teams, a management team committed to your development. Furthermore, Global MTech is providing cross-functional training and development and is the portal for collaboration with many different organizations including R&D, Manufacturing, Supply Chain, Regulation, and Quality.

WHO YOU ARE

You are a technical-oriented person who thrives in a fast-paced team environment. You want to:

  • Lead and support technical Cleaning, Extractable & Leachable, Filter, and Shipping process improvements and portfolio execution activities, with a strong focus on Cleaning.

  • Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines

  • Define and manage deliverables and objectives for safe and compliant execution activities

  • Work cross-functionally across platforms including MTech, VIA, and R&D as well as external CMOs

WHAT YOU WILL DO

You will be working on a strong technical team and be a technical expert and point of contact for troubleshooting, notebook, development, and validation study design and execution activities within the Manufacturing Technology (MTech) function of Vaccines Industrial Affairs (VIA), will perform process-related cleaning development and validation activities across the US MTech portfolio. 

You will be accountable for:

  • Technical contributions to the strategic vision for the future of cleaning validation and implementation

  • Participation in the cleaning validation network within Sanofi 

  • Coaching and mentoring junior personnel and educating/maintaining technical knowledge in the workforce. 

BASIC QUALIFICATIONS

  • Bachelors or Masters in basic sciences, math, engineering, or pharmacy with 2+ years’ experience or Ph.D. with experience in biological processes or analytics in a cGMP environment.

  • The candidate should possess educational and professional experience, commensurate with the position.

PREFERRED QUALIFICATION

  • A minimum of two years experience in cleaning validation in a regulated environment, additional experience in other areas of validation (filter, shipping, extractable & leachable) is a plus

  • Proven experience leading or participating in cross-functional teams

  • Excellent writing, communication, and organizational skills

WHAT WE OFFER 

Sanofi Pasteur provides a total rewards employment offer including, but not limited to competitive pay, industry-leading 401(k) match, immediate participation in comprehensive welfare benefits, tuition reimbursement, a flexible work policy, and generous paid time off. Successful incumbents in the Validation scientist role have gone on to become Cleaning program SMEs, Manufacturing Continuous Improvement managers, and transversal validation group deputy director leaders.

Become a member of MTech US – the high-performing Technical and Science team dedicated to the life-saving mission of Sanofi Pasteur!

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.

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.

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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.

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