Sr Process Engineer

GSK•Marietta, PA

About The Position

Join GSK’s team advancing the manufacturing of drug substances. The Sr Process Engineer develops and optimizes processes for safe and efficient medicine production, working with cross-functional partners committed to science, quality, and continuous improvement. The role provides opportunities to lead projects and contribute to GSK’s mission of uniting science, technology, and talent to get ahead of disease. The position leads process and facility engineering activities for bioprocess equipment and manufacturing systems, including design, procurement, installation, commissioning, validation, and ongoing technical support. It also supports process monitoring and improvement, equipment and technology decisions, technology transfer, site operational excellence, and compliance with GSK standards and applicable quality, safety, and environmental requirements. The engineer works with internal teams and external firms, vendors, consultants, and contractors to deliver compliant process designs and installations.

Requirements

Bachelor’s degree in engineering or a scientific field; a bachelor’s degree is a minimum and absolute requirement.
At least 5 years of process engineering experience in pharmaceutical or medical device manufacturing.
Experience with Good Manufacturing Practices and pharmaceutical or vaccine formulation and filling facilities.
Strong knowledge of aseptic biopharmaceutical 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.
Ability to generate options to resolve problems, prioritize solutions, determine an appropriate course of action, build consensus around recommendations, and implement decisions.
Demonstrated self-directed work habits and verbal and written communication skills.
Commitment to teamwork and working in a team-based culture.
Familiarity with regulatory expectations for electronic records and electronic signatures.
Ability to maintain attention to detail while managing multiple tasks and working with minimal supervision.
Ability to operate cross-functionally and lead in a matrix organization.

Nice To Haves

Strong understanding of GMP related to drug substance processes.
Experience in process validation, risk assessment, and change management.
Proven documentation skills 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.
Good communication skills and a collaborative mindset.

Responsibilities

Lead design, specification, procurement, installation, commissioning, validation, and continued technical support for bioprocess equipment and facility design and operation, including buffer preparation, small-batch reactors, UFDF, formulation, filling, and manufacturing support systems.
Facilitate multidisciplinary teams conducting HAZOPs, FMEAs, process reviews, and SOP development.
Lead or assist in developing local standards and guidelines; author, revise, and review SOPs as needed.
Monitor processes to verify throughput, consistency, and compliance with GSK Bio and industry best practices.
Initiate and execute process improvement projects to address deficiencies and improve throughput.
Facilitate site decisions on standards for process equipment and instruments.
Serve as a primary interface with outside engineering firms on process design, design issues, 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—meet cGMP requirements and 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, control technology, and GSK Bio standards; evaluate new technologies and develop technical solutions to process problems and improve efficiency and throughput.
Ensure validation, quality, engineering, safety, and environmental procedures and regulations are met, maintained, and documented.
Perform or oversee equipment and process simulations to size equipment and systems for intended service.
Participate in site Operational Excellence initiatives and benchmark with other GSK sites to incorporate best practices.
Support commissioning and validation of site systems, including protocol generation (CTP, IO/OQ, and engineering studies), change control, CAPA development and implementation, deviation investigations, and operational Performance Qualification.
Provide technical expertise for site systems during audits, where appropriate.
Participate in technology transfer and functional forums to ensure process equipment and clean utility systems are correctly configured for new or revised manufacturing processes.
Ensure GSK standards and guidelines are applied to projects and participate in developing and updating local policies and procedures.