MSAT NPI Process Validation PPQ

Job Title: MSAT NPI Process Validation PPQ

Location: Toulouse
Department: : MSAT
Reports To: Senior Manager-NPI

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 Process Validation Engineer-NPI 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 Process Validation Engineer-NPI 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:

• Lead Upstream/ Downstream stakeholders for Process Validation at J.POD Toulouse to support commercial GMP manufacturing activities.
• Acting as a subject matter expert and as a leader for PPQ preparation and execution.
• Partner with Product and Process Design, Quality, CQV and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
• Partner with Product and Process Design and with with Manufacturing to coordinate successful efficient scale-up and technology transfer to ensure the successful integration of process knowledge into manufacturing operations.
• Partner with Supply Chain and with Manufacturing to support Bill of Material definition and to develop high-quality batch records, innovative and robust processes
• Acting as a subject matter expert for regulatory and client inspection audits.
• Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
• Apply Operational Excellence principles to lead continuous improvement in NPI activities.

Who You Are:

• Ph.D. (or Masters) degree in relevant field or related program with 10+ (15+) years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading process validation program, PPQ, and commercial manufacturing for biopharmaceutical products.
• Demonstrated leadership capabilities to build and mentor high-performing multi-disciplinary teams, drive change, and influence internal and external stakeholders in GMP pharmaceutical or biotechnology
• Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
• Experience in developing submission packages for pharmaceutical product registration
• Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
• Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
• Technical mastery of cell culture, purification and solution preparation operations using disposable-based manufacturing technologies.
• Excellent interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization.

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.