Location: Delaware
Reports To: Chief Technical Officer (CTO)
Position Overview
The Validation Engineer will ensure all equipment, systems, and processes at GMPLI are qualified and validated in compliance with GMP and global regulatory requirements. This role is critical to ensuring the production of high-quality, compliant water, media, and buffer solutions.
Key Responsibilities
- Develop and execute validation protocols for equipment, utilities, and processes.
- Perform IQ/OQ/PQ activities and document results per regulatory standards.
- Partner with Engineering and Quality to support commissioning activities.
- Maintain validation documentation and ensure audit readiness.
- Drive continuous improvement in validation processes and procedures.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 3+ years of validation experience in pharmaceutical or biotech manufacturing.
- Strong knowledge of IQ/OQ/PQ and GMP validation requirements.
- Excellent technical writing and documentation skills.
Key Competencies
- Regulatory Compliance Expertise
- Technical Accuracy
- Analytical Thinking
- Collaboration Across Departments
- Documentation Excellence