CSV Manager

Toulouse - France

Monthly Salary: Not Disclosed

Posted on: 19 days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: CSV Manager

Location: Toulouse
Department: : MSAT
Reports To: CQV/CSV Senior Manager

About Us: this is who we are

At Just Evotec Biologics we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCUREious with us and see where your curiosity can take you!

The Role: Your challenge in our journey

Were looking for a passionate and curious CSV Manager to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a CSV Manager at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

What Youll Do:

Manage a team of validation engineers and oversee external contractors.
Develop and maintain the Validation Master Plan (VMP).
Supervise and approve validation documentation: protocols reports risk assessments URS IQ/OQ/PQ.
Lead validation lifecycle programs for computerized systems (CSV).
Ensure compliance with quality standards and support regulatory inspections and client audits.
Coordinate cross-functional activities with Quality Engineering Manufacturing Laboratory and IT departments.
Identify and drive continuous improvement and harmonization initiatives in validation practices.

Who You Are:

Masters degree in Engineering Pharmacy Life Sciences or equivalent.
At least 12 years of experience in validation/qualification within the pharmaceutical or biotech industry including 4 years in a managerial role.
Strong knowledge of regulatory standards: EU GMP FDA CFR ICH Q8-Q10-Q12 Annexes 1/11/15.
Proven expertise in computerized systems validation (CSV).
Solid track record in audit management and inspection readiness.
Demonstrated leadership team management and complex project management skills.
Excellent written and verbal communication skills in both English and French.
Analytical mindset organizational strength and ability to thrive in a fast-paced evolving environment.

Why Join Us:

Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.

Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics !

FR : Dans le cadre de sa politique Diversité Evotec étudie à compétences égales toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.

Required Experience:

Manager

Job Title: CSV ManagerLocation: ToulouseDepartment: : MSATReports To: CQV/CSV Senior ManagerAbout Us: this is who we areAt Just Evotec Biologics we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from...