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CSV Manager

il y a 2 semaines

Toulouse, Occitanie, France Evotec Temps plein

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 what's possible. We're on a mission to create a place where curiosity isn't just encouraged—it's celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper?   #BeCUREious with us and see where your curiosity can take you

 

The Role: Your challenge …in our journey

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

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

What You'll 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:

  • Master's 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: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.

  • Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.

  • Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.

  • Innovative Projects: You'll 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 don't just talk about thinking outside the box—we throw the box away. If you've got ideas, we want to hear them.

Are You Still Curious?

If you've read this far, then chances are you've got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you—and 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.