Job Title: Validation Engineer III

Location: Ridgefield, NJ

About the Job

We 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.

• 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.
  

• 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.
  

• 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 andwellness programs and at least 14 weeks' gender-neutral parental leave.