Biotechnology Validation Specialist
1 day ago
We are seeking a skilled Validation Engineer to join our team in the biotechnology industry. In this role, you will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
Your key responsibilities will include drafting, executing, reviewing, and approving validation documentation ensuring it meets cGMP requirements, regulatory requirements, and quality standards. Additionally, you will initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
You will also conduct preventative maintenance and perform risk assessments, recommend process improvements where needed, ensuring compliance with industry standards. Furthermore, you will establish validation standards and develop performance testing and quality control measures.
In this position, you will work alongside a talented team of professionals in an exciting, developing, and diverse biotechnology landscape. You will have the opportunity to grow and develop your skills, working on challenging projects and collaborating with experts in the field.
Requirements
- Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
- 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
- Sound industry knowledge, project proficiency, and autonomy expected.
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