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Principal Manufacturing Compliance Engineer - Framingham Massachusetts
Company: Sanofi Location: Framingham, Massachusetts
Posted On: 04/26/2024
, 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
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