Principal Process Validation Engineer, MTS

Principal Process Validation Engineer, MTS

Title: Principal Process Validation Engineer, MTS
Location: United States-Massachusetts-Allston
Other Locations:
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 .

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).

Principal Process Engineer/Scientist , Process Validation
The Manufacturing Technical Support (MTS) group is responsible for supporting production operations at Genzyme Allston Landing, a large-scale therapeutic protein manufacturing facility. As part of this mission, MTS is establishing a group responsible for process validation (PV) - the full body of evidence, from development through continued process monitoring, demonstrating that the process reliably delivers quality product.

The new PV group within MTS is responsible for designing and implementing the PV program at Allston as part of consent decree remediation activities. The group is also responsible for validating the processes conducted at Allston (including buffer and media preparation, cell culture, and purification operations). The PV group will work with Development, Manufacturing and Quality to identify and remediate gaps in process design/characterization knowledge, design and execute large-scale process qualification studies, and design continued process verification programs to ensure ongoing process control and understanding.

We are seeking a candidate with experience in biopharmaceutical process development or technical support to join the PV team. The scope of responsibilities includes:
* Assisting with the development of PV strategy.
* Creating and revising PV policies, procedures, and templates to ensure alignment with corporate, industry, and regulatory standards.
* Performing gap and risk assessments to determine specific PV requirements and priorities.
* Writing PV plans, protocols, and reports.
* Conducting / coordinating PV studies.
* Advising and training MTS and other Allston staff on PV requirements as part of implementing the PV program.
Key skills:
* Previous experience developing/supporting cGMP bioprocess bulk manufacturing (including cell culture, purification, and/or buffer/media preparation processes).
* Analytical problem-solving skills, including ability to identify critical objectives and design experiments/studies to meet these objectives
* Strong technical writing, presentation, and computational ven ability to work collaboratively as part of cross-functional teams.
Basic qualifications:
* BS in science or engineering with at least 10 years or MS in science or engineering with at least 8 years experience in manufacturing technical support or process development.
* Understanding of current regulatory and industry standards for biopharmaceutical process validation.

Preferred Requirements:
* Experience working within a remediation environment, ideally Consent Decree remediation.
* Experience reviewing validation studies with FDA and other regulatory authorities.
* Experience with technology transfer.