Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
The Senior Computer Systems Validation Specialist (CSV) is directly responsible for managing all CSV activities. The Senior CSV Specialist organizes and manages regular meetings to ensure the follow-up of all tasks linked to CSV activities. This role is responsible for the GMP implementation through Catalent Houston's quality system and feeds continuous quality improvement.
- Serves as the Single Point of Contact for any CSV related questions
- Advise users, as well as clients representative when new computerized system are installed
- Coordinates activities with the help of users, IT and QA department.
- Translate user's needs into technical solutions, taking into account QA requirements, as well as IT technical constraints.
- Ensure first line troubleshooting and support on CSV day to day activities
- Manage improvement/modifications to be performed on computerized systems, in close collaboration with users, QA and IT departments
- Bachelor's degree in Science or technical discipline intermediate with 6 to 8 years relevant Validation experience, preferably working within an FDA regulated manufacturing facility; OR 10 or more years of CSV industry experience.
- Good understanding of cell therapy manufacturing equipment and validation procedures for Clean Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment preferred.
- Solid technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
- Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.
- Understand how to write discrepancies and give a root cause analysis.
- Demonstrated knowledge of procedures, documentation practices, GMP's and regulations associated with the manufacture of biopharmaceuticals.
Key leadership attributes
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross-functional exposure to other areas of within the organization
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 8 paid holidays
- Gain experience in the cutting-edge gene therapy space
- Tuition Reimbursement