QC Validation Engineer

GlaxoSmithKline; 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

Business Introduction

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

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 Guidelines, FDA and other regulatory agency requirements for quality and compliance.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Strong written and verbal communication skills and ability to work collaboratively across functions

Preferred Qualifications

• 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.
• Participate in cross-functional deviations as needed.
• Must have strong technical writing skills.
• Ability to follow written procedures and document results in alignment with GxP requirements.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Maintain a high level of integrity while balancing multiple priorities and responsibilities

What we value

We look for people who are curious, accountable and open to learning. We welcome different perspectives and support inclusion. If you care about precise work that protects patients and helps teams succeed, please apply.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.

Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.