Job Title: Equipment Commissioning and Qualification Specialist

Location: Rensselaer, NY

Duration: 12 months

Job Summary:

Our client is seeking two skilled Equipment Commissioning and Qualification Specialists to join their team. This role is critical for ensuring the effective setup, validation, and qualification of essential equipment within the facility. The specialists will be responsible for all aspects of commissioning, qualification (IQ/OQ/PQ), and developing a comprehensive smoke study program to assess airflow and particle distribution for large equipment. This role requires a deep understanding of fill-finish operations, clean room qualification, and hands-on experience in videography for documentation purposes.

Key Responsibilities:

Commissioning and Qualification: Lead and manage Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes for large equipment, ensuring compliance with regulatory standards and company protocols.

Fill-Finish Operations: Support and oversee fill-finish activities, upholding product quality and Good Manufacturing Practices (GMP).

Videography for Documentation: Create and maintain high-quality video documentation of equipment setup, operational procedures, and validation processes for training, audits, and internal use.

Smoke Study Program Development: Design and implement a smoke study program to assess airflow and particle distribution in clean rooms, identifying areas for improvement and adhering to regulatory standards.

Cross-Functional Collaboration: Collaborate with quality assurance, engineering, and operations teams to ensure comprehensive documentation, communication, and execution of all qualifications and studies.

Qualifications:

Smoke Study Expertise: Strong experience with smoke studies, specifically for large equipment.

Videography Skills: Proficiency in creating video documentation for operational and validation purposes.

Fill Line Experience: Hands-on experience with fill lines and understanding of fill-finish processes.

Clean Room Qualification: Knowledge of clean room protocols and qualification processes.

Equipment Qualification: Extensive experience in equipment qualification, including IQ, OQ, and PQ processes.

Cleaning and Utility Knowledge: Experience with cleaning and utility systems in a regulated environment.

Protocol Development and Execution: Proven ability to write and execute validation protocols.

Additional Requirements:

Willingness to learn, collaborate, and work effectively in a team environment.

Ability to take direction and adapt to a fast-paced work environment.

This role is ideal for individuals with a strong technical background, attention to detail, and a commitment to quality and regulatory standards. Join our client's team to play a vital role in advancing equipment commissioning and qualification within a cutting-edge facility.

Himanshu Lohia

Technical Recruiter

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