Sr Process Engineer

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 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 the ability to generate options to resolve problems, prioritize solutions, determine appropriate course of action, gain consensus on that recommendation, and implement decisions. ·

Preferred Qualifications:

• Must have demonstrated self-direct work habits along with verbal and written communication skills. · Must be a 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 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 with process flow design and process optimization techniques. Ability to analyze data and use results to make clear, actionable recommendations. Good communication skills and a collaborative mindset. 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.
• If you want to be part of a team where your work makes a real difference in patients’ lives, we encourage you to apply. Share your story and tell us how your background and passion can help us improve medicines for billions around the world. We look forward to hearing from you.
• Must have demonstrated self-direct work habits along with verbal and written communication skills. Must be a 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. Able to perform job duties with minimal supervision. Must operate cross-functionally and be able to lead in a matrix organization.

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Skills

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

 

 

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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