Commissioning Specialist
We are seeking a highly skilled and experienced Commissioning Specialist to join our team in a developing biotechnology landscape.
Key Responsibilities
The successful candidate will be responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
* Draft, execute, review, and approve validation documentation to ensure compliance with cGMP requirements, regulatory standards, and quality best practices.
* Initiate and coordinate risk analyses, design reviews, and execute Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Conduct preventative maintenance and perform risk assessments to identify and mitigate potential hazards.
* Establish validation standards and develop performance testing and quality control measures to ensure equipment and system functionality.
Benefits: We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and professional development.
Requirements: To succeed in this role, you should have a strong background in commissioning and qualification, excellent communication skills, and the ability to work effectively in a team environment.