What are the responsibilities and job description for the Associate Engineer position at sanofi?
The Manufacturing team is expanding and seeking an Associate Engineer, Manufacturing – Upstream (Process) to support routine upstream biopharmaceutical manufacturing operations, with a focus on process robustness. The Associate Engineer, Manufacturing – Upstream (Process) supports day‑to‑day upstream manufacturing operations by ensuring that upstream processes (e.g, seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation) are executed consistently, within defined process parameters, and in compliance with GMP requirements. The role operates within a defined process scope and supports Manufacturing Operations by monitoring process performance, analyzing trends, supporting investigations, and contributing to continuous improvement of upstream process robustness. As required, the role may support New Product Introduction (NPI), process startup, and validation activities, primarily from an execution, monitoring, and documentation standpoint. This position reports to the Senior Manager, Manufacturing and works closely with cross‑functional teams. Key Responsibilities 1. Routine Manufacturing & Asset Care Support (Primary Focus) Support routine upstream manufacturing operations within assigned scope. Monitor critical process parameters, trends, and process performance indicators to ensure operations remain within defined control limits. Identify process deviations, abnormalities, or drift; document observations and escalate issues in a timely manner. Provide day‑to‑day technical support to Manufacturing Operations related to upstream process execution. Act as operational process SME for assigned upstream unit operations, supporting safe, compliant, and consistent process performance. Support updates to upstream SOPs, batch records, and process documentation related to new or modified processes. 2. Upstream Process Robustness & Performance Support routine review and trending of upstream process data to identify variability, recurring issues, or opportunities for improvement. Support implementation of process improvements aimed at enhancing robustness, yield, consistency, or operational reliability. Collaborate with MSAT and Automation teams to support effective use of digital tools and process data 3. Support to New Product Introduction (NPI) & Startup (Limited Scope) Support NPI and process startup activities as assigned, such as: Execution support during engineering runs, PPQ, or startup manufacturing Process data collection, verification, and documentation Support of process readiness and operational handover activities Participate in upstream process risk assessments (e.g. FMEA) by gathering information and supporting action tracking. Support updates to upstream SOPs, batch records, and process documentation related to new or modified processes. 4. Deviation, Investigation & CAPA Support Participate in process related deviations and investigations Escalate complex issues to Senior Engineers in a timely manner. 5. GMP, Safety & Compliance Perform assigned activities in compliance with GMP, EHS, and site requirements. Support audit and inspection readiness through accurate and timely documentation. 6. Continuous Improvement Identify and propose improvement opportunities related to upstream process robustness, control, or execution. Participate in OE / Lean / continuous improvement initiatives focused on upstream manufacturing processes. Knowledge, Skills & Competencies Basic understanding of upstream biopharmaceutical processes (e.g. seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation). Working knowledge of GMP requirements and process data integrity principles. Basic data analysis and trending capability to support process performance monitoring. Able to work effectively within cross‑functional teams with appropriate guidance. Demonstrates structured problem‑solving and analytical thinking. Good technical writing and communication skills. Strong team player with a continuous learning mindset. Qualifications / Requirement Diploma or Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or related discipline. 3–4 years of experience in upstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment. Pursue progress, discover extraordinary Better 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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube