Location: Delaware
Reports To: Chief Technical Officer (CTO)
Position Overview
The Validation Consultant will provide specialized expertise to GMPLI’s team, supporting validation projects on an as-needed or contract basis. This role will ensure equipment, utilities, and processes meet GMP and global compliance standards, enabling consistent, high-quality product manufacturing.
Key Responsibilities
- Review, design, and execute validation protocols and reports.
- Provide expert guidance on regulatory compliance during commissioning and qualification activities.
- Train staff on validation best practices and documentation requirements.
- Conduct gap assessments to ensure validation programs meet evolving regulatory expectations.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related discipline.
- 8+ years validation experience in regulated manufacturing, with consulting or contract project background.
- In-depth knowledge of FDA, EMA, and ICH guidelines.
- Strong communication and training skills.
Key Competencies
- Regulatory & Technical Expertise
- Consultative Mindset
- Process Improvement
- Training & Mentorship
- Adaptability