Sr Process Engineer

Position Summary

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. You will collaborate closely with cross-functional partners who share a commitment 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 to improve process throughput.
• Facilitate efforts to define and make decisions on site standards for process equipment and process instruments.
• Act as a 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 that process and project design and installation including FAT and SAT is in compliance with cGMP requirements & GSK Bio standards and that contracts contain appropriate technical specifications and are delivered as required.
• Stay current with technical developments in the field of 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 to 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 the execution of equipment and/or process simulations in order 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 generations (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 as needed to ensure that appropriate process equipment and clean utility systems are in the correct configuration to successfully implement new or revised manufacturing processes.
• Ensure application of GSK standards and Guidelines for all projects and participate in the development and updating of local Policies and Procedures.

Basic Qualifications

• Bachelor's degree in engineering or a scientific field (minimally required, absolute requirement).
• Minimum of 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 Pharms 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, and implement decisions.

Preferred Qualifications

• Demonstrated self-directed work habits along with 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.
• Able to maintain attention to detail while executing multiple tasks with minimal supervision.
• Must operate cross-functionally and be able to 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.