Validation Specialist

Are you ready to take your expertise in validation to the next level? On behalf of our client, we are seeking a talentedValidation Specialistto be a key player in a cutting-edge facility. If you're passionate about driving innovation and ensuring quality in an environment that truly makes a difference, this role is perfect for you.

Why You'll Love This Role:

As a Validation Specialist, you’ll be at the heart of groundbreaking therapies, working within our Facility Engineering department to support GMP manufacturing. You’ll ensure our state-of-the-art equipment, processes, and systems are qualified and compliant, helping us deliver life-changing treatments to patients around the world.

What You’ll Do:

• Lead qualification activities for equipment and systems across manufacturing, quality control, and engineering departments
• Review and approve external validation documents
• Author key validation documents (IQ/OQ/PQ) and oversee protocol execution
• Work closely with cross-functional teams (Engineering, Production, QC, QA) to meet deadlines and close quality records effectively
• Manage re-qualifications and ongoing GMP compliance for our validated systems.
• Assist with CSV and GAMP compliance

What We’re Looking For:

We need someone with strong problem-solving skills, leadership qualities, and a passion for continuous improvement. You’ll need experience in validation and an ability to work with teams to meet high standards of quality and compliance.

Key Competencies:

• Strong leadership and motivation skills
• Innovative and resourceful approach to problem-solving
• Excellent communication, both oral and written
• Thorough understanding of GMP, GDP, and data integrity practices
• A focus on quality and adherence to timelines

Your Background:

You’ll bring a relevant degree (PhD, MSc, or BSc in a biological or biochemistry discipline) and experience in the biotech industry, specifically in molecular biology or process development.

What We Offer:

Be part of a dynamic, forward-thinking company that is pioneering gene therapies with the potential to transform lives. Our cutting-edge facility and collaborative environment will empower you to make a tangible impact.