QC Validation Engineer: Lab Equipment IQ/OQ/PQ Leader

SHPE Houston; Northern (KY); Hybrid; USD 80,000 - 105,000; Full time

Job summary

GSK is seeking a QC Validation Specialist to support IQ/OQ/PQ execution, calibration, and lifecycle management of analytical instruments and laboratory systems. You will collaborate with QA, R&D, and IT to ensure data integrity and regulatory compliance across the QC network.

The role emphasizes strong technical writing, problem solving, and communication to prepare for inspections and maintain validated states in a fast-paced GMP environment.

Qualifications

• Bachelor's degree in a science/engineering field and 2+ years in a cGMP lab environment.
• Experience writing, executing and reviewing IQ/OQ/PQ documentation for QC equipment.
• Strong knowledge of GMP, FDA, NIH guidelines and regulatory requirements.

Responsibilities

• Support all aspects of the Validation Life Cycle in QC from design through operation and improvement, and decommissioning.
• Create new validation approaches for new equipment and maintain validated state.
• Author and execute IQ/OQ/PQ protocols and reports for equipment and computerized systems.
• Perform PM/calibration/requalification of QC equipment and assist with related procedures.
• Represent QC validation during audits and regulatory questions.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Problem Solving

Quality Assurance (QA)

Quality Control (QC)

Risk Awareness

Testing Operations

Education

Bachelor's degree in chemistry, biology, engineering or a related scientific or technical discipline

Tools

LIMS/LES

Job description

GSK is seeking a QC Validation Specialist to support IQ/OQ/PQ execution, calibration, and lifecycle management of analytical instruments and laboratory systems. You will collaborate with QA, R&D, and IT to ensure data integrity and regulatory compliance across the QC network.

The role emphasizes strong technical writing, problem solving, and communication to prepare for inspections and maintain validated states in a fast-paced GMP environment.