Equipment Qualification Engineer

Job Description

Position Title : Equipment Qualification Engineer

Work Location : Millburn, NJ 07041

Assignment Duration : 8 Months

Work Arrangement : Onsite

This position's starting pay is : $50.00 / hr.

Position 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.

Background & Context : The contractor will be responsible for executing qualification protocols (IQ / OQ / PQ), preparing documentation, and ensuring equipment is fit for its 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 compliant equipment 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.
• Support investigations and deviations related to equipment performance.
• Assist in change control processes related to equipment upgrades or replacements.
• Maintain traceability and data integrity throughout the qualification lifecycle.

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Applicant Notices & Disclaimers

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.