QC Validation Engineer

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase speed, quality, and supply.

About the role

This position will support all validation activities in QC. You will manage non-testing systems and processes for QC, including new equipment qualification and existing equipment requalification. Responsible for vendor management and training for on-site calibration of QC equipment. You will ensure laboratory equipment, instruments, and computer systems meet quality and regulatory expectations. This role offers growth, meaningful impact, and a chance to help GSK unite science, technology, and talent to get ahead of disease together.

Responsibilities

• Support all aspects of the Validation Life Cycle in QC from design through operation, improvement, and decommissioning.
• Create new validation approaches for new equipment to align with procedures and standards.
• Qualify QC equipment in accordance with corporate and departmental procedures, maintaining the 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, and reviews.
• Perform PM/calibration/requalification of QC equipment, including temperature and humidity chambers, balances.
• Assist with creation and updates of equipment-related procedures.
• Maintain current knowledge of validation requirements, practices, and procedures, and instruct site personnel participating in validation studies.
• Represent QC for input on the site Validation Master Plan (VMP) and Facility Master Plan (FMP), where appropriate.
• Represent the QC validation function during audits by presenting information and responding to regulatory agency questions.
• Collaborate with QC teams, global teams, support teams, and other sites to ensure compliant processes related to equipment.
• Benchmark with GSK sites to ensure equipment used is optimized and aligned within the network.
• Lead installation, qualification, validation, and lifecycle management of analytical instruments and laboratory computer systems.
• Manage calibration, maintenance, and documentation to meet regulatory and site quality requirements.
• Support validation of computerized systems, access controls, and data integrity practices.
• Lead investigations, change controls, and corrective actions related to equipment, systems, or data.
• Prepare and maintain laboratory procedures, specifications, and validation documentation.
• Train laboratory staff on equipment use, system access, and quality requirements.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.

Requirements

• Bachelor's degree in chemistry, biology, engineering, or a related scientific or technical discipline. Another Bachelor's degree may be considered if the candidate has 5+ years of relevant experience.
• Minimum 5+ years' experience in a regulated laboratory or quality environment, with at least 2+ years in a cGMP-regulated laboratory environment.
• Minimum 2+ years of pharmaceutical experience related to validation of equipment and systems, including writing, execution, and review of IQ/OQ/PQ documentation for QC equipment.
• Practical experience with equipment lifecycle activities: installation, IQ/OQ/PQ, calibration, and maintenance.
• Experience supporting computerized laboratory systems, validation, and integrity.
• Experience writing and executing IQ/OQ/PQ protocols and advanced knowledge of GMPs, NIH Guidelines, FDA, and other regulatory agency requirements for quality and compliance.
• Strong written and verbal communication skills and ability to work collaboratively across functions.

Preferred Qualifications

• Advanced degree (Master's) or certification in validation, quality, or a related discipline.
• Experience preparing for and supporting inspections and audits.
• Familiarity with laboratory systems such as LIMS/LES and instrument software.
• Knowledge of data integrity expectations and relevant standards.
• Experience with laboratory automation, instrument networking, or digital solutions.
• Experience leading readiness projects or cross-functional improvement initiatives.
• Strong technical writing skills and prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ).
• Ability to follow written procedures and document results precisely.
• Intermediate computer skills.

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

Benefits

Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.