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Principal Validation Engineer

Company: Sanofi
Location: Ridgefield
Posted on: June 25, 2022

Job Description:

JOB RESPONSIBILITIESKey Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.Expert knowledge of risk based commissioning, qualification and validation approaches that meet current regulatory requirements, internal standards, and industry practices.Perform validation in a cGMP manufacturing facility managing multiple medium to large size validation projects and 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.Ability to read/interpret engineering drawings and design documents.Demonstrate ability to manage medium to complex CQV projects.Responsible for peer review of validation data packages and present the validation approach and study results to peers and managers.Excellent technical writing and verbal communication skills.Proficiency in Microsoft Office including Word, Excel, PowerPoint, and Project, and Visio.Requires some off-shift availability when necessary (typically 10-20% of the time) potentially including weekends and holidays.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.Strong interpersonal, organizational and technical skills. Capability to work both independently and in a team environment. Strong analytical and communication skills are required.Complete internal and external training.Adhering to all applicable laws and regulations of the places in which we conduct business, as well as Sanofi policies and procedures.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) to ensure high quality deliverables meeting CGMP and Sanofi validation requirements.Demonstrated success working across organizations in highly cross-functional team environment.SME in facility, utility, and equipment commissioning and qualification, and process performance qualification.Provide support to regulatory audits as needed as Validation Subject Matter Expert.Knowledge of core quality systems such as change control, deviations, investigations, CAPA management and document control.Demonstrate problem solving, creative and critical thinking skills.REQUIREMENTSEducation / ExperienceBachelor's degree in engineering/science and 10 years of relevant experience or,Master's degree in engineering /science and 8 years of relevant experience.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.GD-SGLI-GZPDNAt 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.PDN-95395c09-c441-406e-a6aa-76ad15bedd5f

Keywords: Sanofi, New York , Principal Validation Engineer, Engineering , Ridgefield, New York

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