QC Validation Engineer - Elevate Lab Quality & Compliance

GlaxoSmithKline; Marietta (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

GlaxoSmithKline is seeking a QC Validation Specialist to support the Validation Life Cycle in QC, handling IQ/OQ/PQ activities for laboratory equipment and computerized systems. You will lead calibration, lifecycle management and ensure data integrity while collaborating with quality, science, engineering and IT teams.

The role requires 2+ years in a cGMP lab and a degree in a relevant science or engineering field; experience with LIMS/LES and regulatory expectations is preferred.

Qualifications

• Bachelor’s degree in chemistry, biology, engineering or a related scientific/technical discipline; 5+ years experience acceptable in lieu of preferred degrees.
• Minimum 2 years of experience in a cGMP-regulated laboratory environment.
• Experience validating equipment and systems, including IQ/OQ/PQ documentation for QC equipment.

Responsibilities

• Assist with validation lifecycle from design through operation and improvement, including decommissioning.
• Qualification of QC equipment per corporate procedures and maintenance of validated state.
• Author and execute IQ/OQ/PQ protocols and reports for equipment and computerized systems.
• Prepare QC validation documentation such as qualification protocols, URS, master plans and risk assessments.
• Perform PM/calibration/requalification of QC equipment (e.g., chambers, balances) and maintain procedures.

Skills

Communication skills

Attention to detail

Collaboration across functions

Problem solving

Education

Bachelor's degree in chemistry, biology, or engineering

Tools

LIMS/LES

Instrument software

Job description

GlaxoSmithKline is seeking a QC Validation Specialist to support the Validation Life Cycle in QC, handling IQ/OQ/PQ activities for laboratory equipment and computerized systems. You will lead calibration, lifecycle management and ensure data integrity while collaborating with quality, science, engineering and IT teams.

The role requires 2+ years in a cGMP lab and a degree in a relevant science or engineering field; experience with LIMS/LES and regulatory expectations is preferred.