QC Validation Engineer - Shape Lab Quality & Compliance

GSK; United States; On-site; USD 75,000 - 110,000; Full time

Job summary

GlaxoSmithKline is seeking a QC Validation professional to support all validation activities in QC, manage non-testing systems, and ensure equipment and computerized systems meet quality and regulatory expectations. The role leads installation, qualification, validation and lifecycle management of analytical instruments and lab computer systems.

You will collaborate with quality, science, engineering and IT teams, contribute to audits, and help maintain data integrity and GMP compliance.

Qualifications

• Bachelor's degree in chemistry, biology, engineering or related technical field with 5+ years of experience may be considered
• Minimum 2 years in a cGMP-regulated laboratory environment
• Experience validating equipment and systems including IQ/OQ/PQ documentation for QC equipment
• Practical experience with equipment lifecycle activities: installation, IQ/OQ/PQ, calibration and maintenance
• Experience with computerized laboratory systems validation and data integrity

Responsibilities

• Support all aspects of the Validation Life Cycle in QC from design through operation and improvement
• Create new validation approaches for new equipment to align with procedures and standards
• 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 in QC
• Prepare QC validation documentation such as qualification protocols, URS, validation master plans, risk assessments
• Perform PM/calibration/requalification of QC equipment, including temperature and humidity chambers, balances
• Train staff on equipment use, system access and quality requirements

Skills

cGMP experience

IQ/OQ/PQ protocols

calibration

document writing

Education

Bachelor's degree in chemistry/biology/engineering

Tools

LIMS/LES

instrument software

Job description

GlaxoSmithKline is seeking a QC Validation professional to support all validation activities in QC, manage non-testing systems, and ensure equipment and computerized systems meet quality and regulatory expectations. The role leads installation, qualification, validation and lifecycle management of analytical instruments and lab computer systems.

You will collaborate with quality, science, engineering and IT teams, contribute to audits, and help maintain data integrity and GMP compliance.