Sr Process Engineer

GSK•Marietta, PA

About The Position

The Sr Process Engineer develops and optimizes processes for safe, efficient drug-substance manufacturing. The role works with cross-functional partners on process design, equipment and facility operation, process improvement, and technology transfer, contributing to science, quality, and continuous improvement. It includes opportunities to lead projects and support the implementation of manufacturing technologies and processes. The engineer leads or supports the lifecycle of bioprocess equipment and facility design, from specification and procurement through installation, commissioning, validation, and ongoing technical support. The position also provides technical expertise for process and project design, ensures applicable cGMP and company standards are met, and supports operational excellence, audits, and site manufacturing systems.

Requirements

Bachelor’s degree in engineering or a scientific field; the posting states a bachelor’s degree is minimally required and an 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.
Experience and 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.
Demonstrated ability to generate options for resolving problems, prioritize solutions, determine an appropriate course of action, gain consensus, and implement decisions.

Nice To Haves

Self-directed work habits and strong 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 handling multiple tasks with minimal supervision.
Ability to work cross-functionally and lead in a matrix organization.
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.
Collaborative mindset and good communication skills.

Responsibilities

Lead the design, specification, procurement, installation, commissioning, validation, and continued technical support of bioprocess equipment and facility design and operation, including buffer preparation, small batch reactors, UFDF, formulation, filling, and manufacturing support equipment.
Facilitate multidisciplinary HAZOPs, FMEAs, process reviews, and SOP development; contribute to local standards and guidelines; and author, revise, and review SOPs.
Monitor processes to verify throughput, consistency, and compliance with GSK Bio and industry best practices; initiate and execute improvement projects to resolve deficiencies or improve throughput.
Facilitate decisions on site standards for process equipment and instruments.
Serve as a primary interface with external engineering consultants on process design, 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 are delivered as required by contract.
Keep current with developments in vaccine formulation, manufacturing equipment and design, control technology, and GSK-Bio standards; evaluate technologies and develop solutions to improve process 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 appropriately.
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 controls, CAPA development and implementation, deviation investigations, and operational Performance Qualification efforts.
Provide technical expertise for site systems during audits, as appropriate.
Participate in technology transfer efforts and functional forums to ensure process equipment and clean utility systems are configured to support new or revised manufacturing processes.
Ensure GSK standards and guidelines are applied to projects and participate in developing and updating local policies and procedures.