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

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment.
• Good understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
• Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment.
• Proficient in writing and reviewing technical documentation.
• Excellent organizational and communication skills.
• Experience with computer system validation (CSV) and data integrity principles.
• Ability to work independently and manage multiple priorities.