Quality Equipment Qualification Engineer

Summary:
We are seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols (IQ/OQ/PQ), preparing documentation, and ensuring equipment is fit for intended use in a pharmaceutical quality control environment.

Key Responsibilities:

• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

• Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and appropriate qualification.

• Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation.

• Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines.

Education & Experience...