Sr Process Engineer

About the role

GSK manufactures and supplies reliable, high-quality medicines and vaccines to meet patients' needs. Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024. Technology is transforming how we manufacture, enabling increased speed, quality, and scale through smart manufacturing technologies including robotics, digital solutions, and artificial intelligence.

Join a team dedicated to advancing the manufacturing of drug substances that improve lives. In this role, you will develop and optimize processes to make medicines safely and efficiently, collaborating closely with cross-functional partners committed to science, quality, and continuous improvement. We value engineers who are curious, practical problem solvers and strong communicators. This role offers opportunities to grow your skills, lead meaningful projects, and contribute to our mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities

• Lead the design, specification, procurement, installation, commissioning, validation, and continued technical support of bioprocess equipment and facility design/operation including buffer preparation, small batch reactors, UFDF, formulation, filling, and manufacturing support (COPSOP, Part Washer, Autoclave)
• Facilitate multi-disciplined teams in the performance of HAZOPs, FMEAs, process reviews, and SOP development efforts
• Lead or assist with development of local standards and guidelines
• Author, revise, and review SOPs as required
• Perform process monitoring to verify process throughput, consistency, and compliance with GSK Bio and industry accepted best practices
• Initiate and execute process improvement projects to address process deficiencies or improve process throughput
• Facilitate efforts to define and make decisions on site standards for process equipment and process instruments
• Act as primary interface with outside engineering consulting firms on process design projects, process design issues, interpretation of Owner project requirements, Code compliance, equipment selection, value engineering, construction, and implementation
• Manage vendors, consultants, and contractors to ensure process and project design and installation (including FAT and SAT) complies with cGMP requirements & GSK Bio standards, and that contracts contain appropriate technical specifications and are delivered as required
• Stay current with technical developments in vaccine formulation and manufacturing equipment design, equipment, control technology, and GSK-Bio Standards
• Evaluate new technologies and provide technical solutions to solve process problems and improve process efficiency and throughput
• Ensure all validation, quality, engineering, safety, and environmental procedures and regulations are met, maintained, and documented appropriately
• Perform or oversee execution of equipment and/or process simulations to appropriately size equipment and systems for their intended service
• Participate in site Operational Excellence initiatives
• Perform benchmarking with other GSK sites to incorporate best practices
• Support commissioning and validation efforts of site systems including protocol generation (CTP, IO/OQ, Engineering Studies), change control initiations, CAPA development and implementation, deviation investigations, and support operations Performance Qualification efforts
• During audits, provide technical expertise for site systems where appropriate
• Participate in Technology Transfer efforts and Functional Forums to ensure appropriate process equipment and clean utility systems are in correct configuration for new or revised manufacturing processes
• Ensure application of GSK standards and Guidelines for all projects and participate in development and updating of local Policies and Procedures

Requirements

• Bachelor's degree in engineering or a scientific field (absolute requirement)
• Minimum 5+ years of experience in process engineering within pharmaceutical or medical device manufacturing
• Experience with Good Manufacturing Practices, Pharma or Vaccine formulation and filling facilities
• Experience and strong knowledge with Aseptic Bio Pharma operations, equipment, and facility design and operation
• Experience with process flow design and process optimization techniques
• Ability to analyze data and use results to make clear, actionable recommendations
• Technical understanding of the pharmaceutical industry and engineering practices
• Demonstrated ability to generate options to resolve problems, prioritize solutions, determine appropriate course of action, gain consensus on recommendations, and implement decisions

Preferred qualifications

• Demonstrated self-directed work habits with strong verbal and written communication skills
• Committed team player prepared to work in and embrace a team-based culture
• Familiarity with regulatory expectations regarding electronic records and electronic signatures
• Ability to maintain attention to detail while executing multiple tasks with minimal supervision
• Ability to operate cross-functionally and lead in a matrix organization
• Strong understanding of Good Manufacturing Practices (GMP) related to drug substance processes
• Experience in process validation, risk assessment, and change management
• Proven skills in documentation for compliance and regulatory audits
• Leadership experience or ability to influence cross-functional teams
• Experience preparing and delivering presentations and technical reports
• Familiarity with regulatory inspection processes in pharmaceutical manufacturing

Skills

• Asset Life Cycle Management
• Data Integrity
• Digital Fluency
• GxP Regulations
• Lean Management
• Manufacturing Technologies
• Pharmaceutical Manufacturing
• Problem Solving
• Risk Awareness
• Standards Compliance

Benefits

GSK offers a comprehensive benefits program for US employees. Details are available in the GSK US Benefits Summary.