Sr Process Engineer

GSK; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

GSK is seeking a process engineer to advance manufacturing of drug substances and vaccines. You will develop and optimize processes to produce medicines safely and efficiently, collaborating with cross-functional partners who value science, quality and continuous improvement.

We value engineers who are curious, practical problem solvers and strong communicators. This role provides opportunities to lead meaningful projects and contribute to delivering high-quality medicines to patients.

Qualifications

• Bachelor's degree in engineering or science is required.
• Minimum 5+ years of process engineering experience in pharma or medical device manufacturing.
• Experience with GMP, vaccine or pharma formulation and filling facilities.

Responsibilities

• Lead design, procurement, installation, validation and support of bioprocess equipment and facilities.
• Coordinate cross-functional teams; develop SOPs and device standards; improve throughput.
• Interface with outside engineering firms on design issues and compliance.
• Manage vendors and contractors to ensure cGMP compliance and project success.
• Stay current with tech developments in vaccine/formulation and equipment design.

Skills

Process engineering

GMP experience

Education

Bachelor's degree in engineering

Job description

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 efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product 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

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

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead the design, specification, procurement, installation, commissioning, validation, and continued technical support of in bioprocess equipment and facility design / operation including buffer preparation, small batch reactors, UFDF, formulation, filling, 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. Will 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 for a scientific field. A bachelor's is minimally required, and an absolute requirement for this role.
• 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 knowled