Highlight
Summary
About the Role
About You
- Bachelor's or master's degree in chemistry, Engineering, Life Sciences, or a related technical field.
- Experience in analytical equipment qualification in a GMP-regulated medical device or pharmaceutical environment.
- In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211, 11), GAMP 5, and ISO 13485.
- Experience qualifying and maintaining manufacturing equipment.
- Familiarity with electronic document systems, validation tools, and computerized system validation.
- Certification in Lean Six Sigma, ASQ, or ISPE.
- Experience supporting global harmonization of validation practices across multi-site environments.
- Working knowledge of medical device testing requirements, especially for infusion devices, sensors, or diagnostic platforms.
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!