Biotechnology Commissioning and Qualification Engineer
We are seeking a highly skilled Biotechnology Commissioning and Qualification Engineer to join our team. As a key member of our organization, you will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
* Develop and execute validation documentation, including protocols and reports, to ensure compliance with cGMP requirements and quality standards.
* Conduct risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ activities.
* Collaborate with cross-functional teams to develop and implement process improvements, ensuring compliance with industry standards.
* Establish validation standards and develop performance testing and quality control measures.
* Execute process equipment and clean room validation.
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.
* Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
* Understands current risk-based validation approaches.
* Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
* Excellent organizational skills and attention to detail required.
This is an exciting opportunity to join a dynamic team and contribute to the success of our organization.