The Role & Responsibilities
As a CSV Specialist, you will play a key role in ensuring compliance and integrity of computerized systems within a leading pharmaceutical environment. Your responsibilities will include:
Validation Projects: Execute validation activities for process equipment, laboratory instruments, and computerized systems in line with different specific guidelines
Validation Deliverables: Prepare and maintain documentation such as project plans, user requirements, risk assessments, test protocols, SOPs, and periodic reviews
Regulatory Compliance: Ensure adherence to US regulations, and other relevant regulations, as well as EHS requirements
Collaboration & Continuous Improvement: Work closely with manufacturing, IT, and laboratory teams to implement validation programs and foster a culture of continuous improvement.
Profile / Requirements :
Your Profile
You hold a Bachelor's or Master's degree in Computer Science, STEM, or related scientific field
You have a strong knowledge of CSV and IT regulations
You are familiar with GMP systems and Excel validation workflows
You understand Project Management and Software Development Life Cycles
Excellent communication, leadership, and problem-solving skills
You are able to work independently and manage multiple priorities under strict deadlines.
The Recruitment Process
At Nalys, our hiring process is designed to be transparent and engaging:
Olivia Braszko, TA Specialist at Nalys, will review your application and schedule an initial screening to answer your questions and assess your expectations
A second interview will be held with one of our Technical Referents to go deeper in technical aspects of the position
Final interview with our Business Unit Director, Jimmy Rousseaux.
If you're passionate about compliance and want to contribute to the success of a global pharmaceutical leader, we'd love to hear from you!