QC Validation Engineer: Ensure GMP-Ready Lab Equipment

GSK; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

GSK is seeking a QC Validation professional to support all validation activities in the QC domain. You will manage non-testing systems, qualification of new equipment, and calibration programs, aligning with corporate standards.

The role involves IQ/OQ/PQ execution, documentation, and collaboration with quality, science, engineering and IT teams. Ideal candidates have a chemistry/biology/engineering background with cGMP experience and strong documentation skills to ensure regulatory compliance

Qualifications

• Bachelor's degree in a scientific/technical field with 5+ years of related experience.
• Minimum 2 years in a cGMP-regulated laboratory environment.
• Experience writing, executing and reviewing IQ/OQ/PQ documentation for QC equipment.
• Practical experience with equipment lifecycle activities: installation, calibration and maintenance.

Responsibilities

• Support all aspects of the Validation Life Cycle in QC from design through operation and improvement.
• Create validation approaches for new equipment and maintain validated state.
• Author and execute IQ/OQ/PQ protocols and reports for equipment and computerized systems in QC.
• Train laboratory staff on equipment use and quality requirements.
• Represent QC validation during audits and regulatory inquiries.

Skills

QC Validation

IQ/OQ/PQ Execution

Regulatory Audits

Problem Solving

Education

Bachelor's degree in chemistry/biology/engineering

Tools

Laboratory computer systems

Job description

GSK is seeking a QC Validation professional to support all validation activities in the QC domain. You will manage non-testing systems, qualification of new equipment, and calibration programs, aligning with corporate standards.

The role involves IQ/OQ/PQ execution, documentation, and collaboration with quality, science, engineering and IT teams. Ideal candidates have a chemistry/biology/engineering background with cGMP experience and strong documentation skills to ensure regulatory compliance