Location: Raleigh-Durham, NC
Who We Are
Enzyvant is a commercial-stage biotechnology company on the leading edge of regenerative medicine for rare diseases. Our lead asset is FDA-approved RETHYMIC®, a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. It is an exciting time for the Enzyvant team as we deliver on our patient purpose and execute on our bold vision for growth.
Patients are the heart and soul of Enzyvant, inspiring deep meaning, passion, and purpose in our work. They are all the reasons for why, how, and what we do. At Enzyvant, we see a world where the promise of our breakthrough biotechnologies is fully realized to transform the lives of patients battling devastating rare diseases. To achieve this vision, we are pursuing new uses and geographies for our biotechnologies and providing extensive support to help families navigate the complexity of rare diseases with our Enzyvant Connect program.
The Enzyvant team includes some of the most innovative talent in the regenerative medicine sector today. We attract people in biotech who want to make their mark in regenerative medicine and deliver truly meaningful, life-changing solutions for patients. Our company culture values teamwork, innovation, empowerment, and integrity. Enzyvant has a small company feel with the reach and resources of our global parent company Sumitovant Biopharma Ltd. (wholly owned by Sumitomo Pharma Co., Ltd.)
The Sr Engineer I, CMC Engineering and Validation will perform equipment support activities and provide engineering technical support to the manufacturing and utility areas of Enzyvant’s new cGMP manufacturing facility to produce RETHYMIC and clinical programs. The Sr Engineer I reports to the Senior Director of Engineering & Validation.
- Troubleshoots equipment systems and associated automation systems for production and utility equipment.
- Identifies and leads equipment related capital projects.
- Directs and supports the design, specification, and installation of new or modified equipment.
- Develops and supports equipment commissioning and validation activities.
- In collaboration with the Quality Assurance department, ensures that all activities are executed in compliance with regulatory guidelines.
- Develops preventative maintenance and calibration requirements for new equipment and instruments
- Maintains personal training and goal development/completion.
- Manages and provides direction to contractors.
- Ensures production equipment meet cGMP’s and are regulatory inspection ready. Support investigations and associated CAPAs as required.
- Contributes to risk analysis and mitigation plans to ensure product quality.
- Works closely with cross-functional teams (e.g., manufacturing and quality) to meet production and project milestones.
- Utilizes project management tools such as schedules, action lists, and clear scope definition to ensure the timely implementation of equipment improvements and compliance task (e.g., change controls, investigations, and corrective and preventative actions).
- Regularly communicates with internal and external stakeholders including presentation of initiatives to senior management.
- Minimum of 4 years of relevant pharmaceutical/biotechnology experience.
- Bachelor’s degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences or equivalent
- Experience with sterile or aseptic processing equipment and GMP manufacturing is required.
- Experience supporting isolator technology and associated air handling equipment is preferred.
- Experience with contractor management is preferred
- Ability to work on-site and periodic on-call availability is required