VALIDATION ENGINEER III

Company: Sanofi Group
Location: Ridgefield
Posted on: October 1, 2024

Job Description:

Job Title: Validation Engineer IIILocation: Ridgefield, NJAbout the JobWe deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.Your job, as Validation Engineer III within our Quality Assurance (QA) Validation group, will be to write and execute protocols and write reports for medium to complex equipment/systems.The Principal Validation Engineer position is part of Quality Assurance (QA) Validation. The Principal Validation Engineer will report to either the Validation Manager or directly to the Associate Director of Validation. The position is required to work independently. This position is responsible for writing and executing protocols and writing reports for medium to complex equipment and/or systems. Responsible for commissioning, qualification and validation activities related to one or more of the following areas: FAT, SAT, DQ, IQ, OQ, PQ, PPQ and requalification activities for facilities, utilities, equipment, cleaning, and sterilization.For computer system validation, this position is responsible for writing and/or reviewing the following: URS, FRS, DS, ERES/GxP Assessment, and annual Periodic Reviews.Main Responsibilities*Requires some off-shift availability when necessary (typically 10-20% of the time) potentially including weekends and holidays.

• Perform validation in a cGMP manufacturing facility managing multiple medium- to- large size validation projects, providing technical assistance to less experienced technicians/engineers.
• Write, review and approve qualification/validation protocols and reports as well as execute protocols; Resolve protocol discrepancies and deviations.
• Demonstrate ability to manage medium to complex CQV projects.
• Responsible for peer review of validation data packages and to present the validation approach and study results to peers and managers.
• Generate, review and approve deviations, CAPAs, perform/lead investigations and root cause analysis.
• Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing, Engineering, and MSAT (Manufacturing Science Analytics Technology-) to ensure high quality deliverables meeting cGMP and Sanofi validation.
• Complete internal and external training, as required.About You
  • Bachelor's degree in engineering or science and 10+ years of relevant experience or master's degree in engineering or science and 8+ years of relevant experience.
  • Strong computer system validation experience is a must.
  • Expert knowledge of risk-based commissioning, qualification and validation approaches that meet current regulatory requirements, internal standards, and industry practices.
  • Knowledge of Validation Lifecycle Approach.
  • Advanced understanding of 21 CFR Part 11, cGMP, and other regulatory guidance for manufacturing equipment and automated processing systems.
  • Proficient in use of GE/Kaye Validator and data acquisition systems and the ability to read/interpret engineering drawings and design documents preferred but not required.
  • Ability to read/interpret engineering drawings and design documents. preferred but not required.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.------
    • 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 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.Pursue progress , discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !US and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)

Keywords: Sanofi Group, Stratford , VALIDATION ENGINEER III, Engineering , Ridgefield, Connecticut