Equipment Commissioning and Qualification Specialist

Job title : Equipment Commissioning and Qualification Specialist

Location : Onsite 5 days Rensselaer, NY

Duration : 1+ year

Job description / summary : Our client is seeking an experienced Equipment Commissioning and Qualification Specialist to join our team at Regeneron.

This role is essential in ensuring the seamless setup, validation, and qualification of critical equipment within our facility.

The ideal candidate will have a strong background in IQ / OQ / PQ processes, fill-finish manufacturing, and videography.

Additionally, they will play a key role in designing and implementing a comprehensive smoke study program. This person needs to know and understand the whole process of smoke studies for large equipment.

This person on a daily basis will be creating the smoke study program, writing protocols, executing protocols, videography and using that equipment.

In order to meet the needs of this role, the individual must have extensive experience they can speak to with the following :

• Smoke Studies, specifically for large equipment
• Videography
• Experience working with fill lines
• Experience working with cleaning rooms
• Know and have experience with clean room qualification
• Experience with equipment qualification (IQ, OQ, PQ)
• Cleaning and Utility experience
• Writing protocols,
• Strong Executing protocols skills

Key Responsibilities :

Commissioning and Qualification : Oversee installation and qualification processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for large equipment.

Ensure that all processes align with regulatory standards and company protocols.

• Fill Finish : Lead and support fill-finish operations, ensuring product quality and adherence to Good Manufacturing Practices (GMP).
• Videography for Documentation : Create and manage high-quality video documentation for the equipment setup, operational procedures, and validation processes.

This includes developing video resources for training, audit purposes, and internal use.

Smoke Study Program Development : Develop and implement a smoke study program to assess airflow patterns and particle distribution.

Ensure the study adheres to regulatory standards and effectively identifies areas for improvement.

Cross-Functional Collaboration : Work closely with quality assurance, engineering, and operations teams to ensure all qualifications and studies are thoroughly documented, communicated, and executed.

Additional requirements :

• Willingness to learn and collaborate
• Work well in a team environment
• Willingness to take direction well
6 days ago