QC Validation Engineer

GSK•Marietta, PA

About The Position

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.

Requirements

Bachelor’s degree in chemistry, biology, engineering or a related scientific or technical discipline or another Bachelors' degree may be considered in lieu of the preferred degrees listed if the candidate has 5 + plus years of experience.
Minimum 5 + years’ experience in a regulated laboratory or quality environment with a minimum of 2 + years' 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.

Nice To Haves

Advanced degree (Master’s) or certification in validation, quality or 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.
Participate in cross-functional deviations as needed.
Must have strong technical writing skills.
Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
Ability to follow written procedures and document results in a neat and precise manner.
Intermediate computer skills required.
Maintain attention to detail, while completing multiple or repetitive tasks.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.

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.