Validation Specialist
4 weeks ago
Validation Specialist
Are you ready to take your expertise in validation to the next level? On behalf of our client, we are seeking a talented Validation Specialist to 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.
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