Principal Manufacturing Compliance Engineer

Company: Sanofi
Location: Framingham
Posted on: April 23, 2024

Job Description:

, validation principles, and applicable regulations

• Extensive experience with Quality Management Systems.
• Ability to learn and operate various enterprise systems including LIMS, SAP, OSI/PI, EMS, BMS, is required
• Regardless of format, able to carry all technical communications which will allow the end-user, specifically QA personnel and regulatory inspectors, to arrive at the intended conclusions.
• Knowledge of GXP regulations and guidance.
• Ability to effectively coach and train employees.
• Demonstrate high-level of communication for cross-functionally and across levels, including timely identification of potential sources of conflict and resolve independently or escalate to stakeholders promptly.
• Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups
• Strong ability to balances the speed of delivering work with quality and shows commitment to make improvements in both aspects
• Demonstrate a high degree of engagement and involvement in all job-related activities. Catalyst for selecting methods, techniques and evaluation criteria for obtaining results. Mentor junior members of team on technical topics. May potentially be a Qualified Trainer on investigation processPreferred Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Chemical Engineering.
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
• Keeps tasks (deviations, CAPA, or CCR) on schedule, tracks them carefully, and delivers results on time; seeks assistance to solve a problem quickly to adhere to on-time delivery
• Experience with project management
• Experience in supervisory teams
• Ability to lead staff in absence to people managerSpecial Working Conditions
  • Ability to gown and gain entry to manufacturing areas.
  • Ability to work off shift hours, seldom, to support product releaseSanofi 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.Learn more about Sanofi M&S: #GD-SG#LI-GZPursue 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 and check out our Diversity Equity and Inclusion actions at !

Keywords: Sanofi, Framingham , Principal Manufacturing Compliance Engineer, Engineering , Framingham, Massachusetts