QC Validation Engineer: IQ/OQ/PQ, Calibration & Lab Systems

Biopharma Careers; Marietta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK US in Marietta seeks a QC validation specialist to support the Validation Life Cycle in QC, from design through operation and improvement, including qualification of QC equipment and lifecycle management of analytical instruments.

You will author IQ/OQ/PQ protocols, train staff, and collaborate with QA, QC, and IT to ensure data integrity and regulatory compliance in a fast-paced manufacturing environment.

Qualifications

• Bachelor’s degree in chemistry, biology, engineering or a related scientific or technical discipline; 5+ 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.

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.

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

Education

Bachelor's degree in chemistry, biology, engineering or related field

Tools

LIMS/LES

Instrument Software

Job description

GSK US in Marietta seeks a QC validation specialist to support the Validation Life Cycle in QC, from design through operation and improvement, including qualification of QC equipment and lifecycle management of analytical instruments.

You will author IQ/OQ/PQ protocols, train staff, and collaborate with QA, QC, and IT to ensure data integrity and regulatory compliance in a fast-paced manufacturing environment.