One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
The Integrated Work Plan (IWP) is Framingham Biologics efforts to move towards an improved level of compliance by remediating our Quality Systems to the Corporate Quality Standards. One element of the IWP is revalidation of many existing processes and unit operations at Framingham Biologics.
This position will report to the Process Control / Process Validation Strategy (PCS/PV) Associate Director. This position will also work closely with the IWP Lead, site subject matter experts and the Allston Site Consent Decree teams to meet the Work Plan deliverables and milestones for Process Validation (PV).
As part of the PCS/PV team, this position will lead or participate in work related to designing and implementing PCS and OCS documents and developing PV strategies. As part of the IWP, these documents and strategies must all meet Corporate Quality and regulatory standards and be consistent with industry best practices. This will include all processes from buffer and media preparation to cell culture and purification operations. This PCS/PV group will work seamlessly with the IWP teams to identify and remediate gaps in process design/characterization knowledge, lead the design of large-scale process qualification studies and of a continued process verification program to ensure ongoing process control and understanding.
The Process Engineer III/Scientist (Process Validation) is responsible for helping to implement the IWP activities. This role will participate in the Process Validation remediation team to ensure that the appropriate needs are identified and are included in the remediation plan.
The Process Engineer III/Scientist (Process Validation) is responsible for:
· Leading or participating in gap assessments between the current operational state and approved Corporate Quality Standards.
· Partnering with Validation, Quality and MTS to revise key operational documents, processes and practices.
· Ensuring the 'to be' business process for Process Validation is correct and helping design the future state process as required.
Designing, coordinating, and conducting Process Validation studies in Framingham Biologics according to the previously defined future state process.
· Versatile learner that is comfortable with ambiguity and complexity.
· Ability to make courageous decisions, while being candid and direct.
· Ability to think beyond their sphere of influence to see what is not obvious and the potential impact.
· Ability to continuously look internally and externally for best practices; comfortable with challenging the status quo and generating successful new ideas that improve business performance.
· Set ambitious and realistic goals, drive for results and be accountable for those results.
· Build trust and collaboration by delivering exceptional service.
BS in science or engineering with at least 8 years experience in manufacturing technical support or process development for cGMP bioprocess bulk manufacturing (cell culture, purification, and/or buffer/media preparation), or MS in science or engineering with at least 6 years experience. Understanding of current regulatory and industry standards for biotech/biopharmaceutical Process Validation. Clear understanding of cGMP via experience of working in regulated biotech/pharmaceutical environment. Experience with technology transfer. Strong analytical problem-solving skills, including ability to identify critical objectives and activities required to meet these objectives. Skilled communicator with a keen eye for detail. Proven ability to work collaboratively as part of a cross-functional team.
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