QC Validation Engineer

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

Business Introduction:

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 not just core to our operations; it's 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 the speed, quality and supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

This position will support all validation activities in QC. Manages 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. Directly responsible for the preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities in alignment with divisional corporate standards. You will ensure laboratory equipment, instruments and computer systems meet quality and regulatory expectations. You will lead validation, calibration and lifecycle activities while working with quality, science, engineering and IT teams. We value clear communicators who solve problems practically and build trusted relationships. 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 and improvement, and decommissioning.
• Create new validation approaches for new equipment to align with procedures and standards. Responsible for the qualification of QC equipment in accordance with corporate and departmental procedures, as well as the 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, 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 VMP (Validation Master Plan) and FMP (Facility Master Plan), where appropriate.
• Represent the QC validation function during audits by presenting information and responding to regulatory agency questions related to the validation program and specific validation studies.
• Collaborate with QC teams, global team, support teams, and other sites to ensure compliant processes as related to equipment. Benchmark with GSK sites to ensure equipment used is optimized and in alignment 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.

Basic Qualifications:

• Bachelor's degree in chemistry, biology, engineering or a related scientific or technical discipline another degree may be considered in lieu of the preferred degrees listed if the candidate has 5 + plus years of experience.
• Minimum of 2 years of experience in cGMP-regulated laboratory environment.
• Minimum of 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 with writing and executing IQ/OQ/PQ protocols and an advanced knowledge of GMP's, NIH Guidel