USA-Process Engineer II (Engineering)

Process Engineer II – Framingham, MA 01701 – 12 Months We are seeking a detail-oriented and motivated Process Engineer to join the BioProcess Engineering (BPE) department, part of the Sanofi Global CMC Development organization. This role provides hands‑on support across technology transfer, process data management, and manufacturing support activities within a dynamic, cross‑functional environment. The ideal candidate is a self‑starter with a strong foundation in bioprocess sciences, a structured approach to data handling, and an interest in contributing to digitalization and continuous improvement initiatives across the GMP manufacturing network. Key Responsibilities Support technology transfer activities by collecting, organizing, and maintaining process data, batch records, and technical documentation throughout transfer planning and execution phases. Perform data verification, reconciliation, and integrity checks to ensure process information is accurate, traceable, and fit for technical review and regulatory reporting. Maintain and update process trackers, study logs, document repositories, and readiness dashboards used to monitor transfer milestones and action items. Conduct routine data trending, charting, and analysis to support process monitoring, flag potential inconsistencies, and surface opportunities for process improvement. Assist in preparing technical summaries, transfer reports, gap assessments, presentations, and cross‑functional meeting materials in support of senior engineers and program leads. Support investigation and deviation activities by compiling relevant process data, organizing supporting documentation, and coordinating information requests across functions. Contribute to digitalization and data modernization efforts, including the development or maintenance of dashboards, structured data templates, automated trackers, and workflow tools (e.g., Excel‑based tools, Power BI, or similar platforms). Participate in cross‑functional meetings and facilitate clear communication of data findings, open action items, and transfer status updates. Basic Qualifications Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, or a related life sciences field with a minimum of 2 - 4 years of relevant industry experience; OR a Master's degree with a minimum of 1 - 2 years of experience in biopharmaceutical manufacturing, process engineering, or process development. Familiarity with upstream and/or downstream bioprocess unit operations (e.g., cell culture, chromatography, filtration) and GMP manufacturing environments. Working proficiency in Microsoft Excel; comfort with data review, process trending, and technical documentation systems. Strong attention to detail, organizational discipline, and the ability to manage multiple priorities within defined timelines. Effective written and verbal communication skills in a cross‑functional team setting. Preferred Qualifications Prior exposure to technology transfer, process characterization, process validation, or manufacturing support activities in a GMP biologics setting. Experience with data visualization tools, process analytics platforms, or digital workflow development. Familiarity with quality systems including deviations, CAPAs, change controls, and investigation documentation. Exposure to external manufacturing partnerships or CDMO collaboration models. Experience across multiple biologic modalities (e.g., mammalian, microbial, etc.). Special Working Conditions Ability to gown and work in classified GMP manufacturing areas as needed. Ability to work flexible hours to support manufacturing schedules or cross‑site coordination across time zones. Working in BioProcess Engineering The BioProcess Engineering group sits at the intersection of development and manufacturing, offering this role unique visibility into CMC strategy, tech transfer execution, and manufacturing support across a global network. Team members regularly collaborate with Operations, Quality, Regulatory, Supply Chain, and CMC Development - making this an outstanding opportunity for a junior professional that is looking to build broad biopharma expertise and accelerate their career growth. #J-18808-Ljbffr Creative Solutions Services, LLC