We are currently seeking a motivated candidate for the position of Associate Director of Engineering to join the Sanofi’s BioProcess Engineering (BPE) organization in Framingham, Massachusetts. The site is responsible for the development, characterization, scale-up, execution, and transfer of cell culture, purification, and fill finish processes for preclinical, clinical, and commercial manufacturing of biologics in both non-cGMP and cGMP settings.
The Project Engineering department provides project management, engineering and technical support to the R&D and cGMP Clinical Manufacturing sites in Framingham. This team supports site-level CAPEX and OPEX projects and provides day-to-day engineering support to the R&D Clinical Manufacturing group. This includes development of concept, design, fabrication, and the commissioning and qualification of process and other systems.
- Provide engineering oversight, manage workload and staff assignments, set priorities and objectives, make decisions and foster a spirit of commitment to customers, innovation while striving for results.
- Provide technical leadership covering a wide variety of process equipment systems used in clinical Biologics Manufacturing, Purification and Fill Finish operations
- Work with the BPE Tech Transfer team in the development and/or technology transfer of new solutions and modifications to our existing manufacturing process systems
- Develop team members by providing performance assessments, coaching, introducing technical alternatives, and delivering innovative solutions to meet business needs.
- Ensure customers and stakeholders receive timely engineering solutions and services.
- Ensure process and equipment engineering designs and solutions follow regulatory guidance.
- Ensure solutions satisfy the needs of internal customers in accordance with company guidelines, HSE requirements and procedures while meeting budget and schedule commitments.
- Manage the Capital budget planning process
- Identify and remove any issues or overlaps so that the team works smoothly and effectively
- Ensure compliance to HSE and Corporate standards
- Bachelor’s degree in Mechanical or Chemical Engineering or related discipline with a minimum of 12 years of relevant experience
- Experience in a cGMP manufacturing environment
- Experience managing people and teams
- Excellent problem-solving skills
- Experience with Design metrics to measure business impact
- Extensive working knowledge of pharmaceutical/biotech processes.
- Extensive working knowledge of pharmaceutical/biotech process equipment
- Progressive engineering work experience within the Biotechnology or Pharmaceutical industry
- General knowledge of other related disciplines such as Automation, I&C, Electrical
- Experience working in matrix environment
- Experience with change management and/or continuous improvement tools
- Working knowledge of maintenance practices including calibration and reliability engineering
Special Working Conditions
- Ability to gown and gain entry to manufacturing areas