Risk Engineer Jobs in Raleigh, NC (NOW HIRING)

Business Summary:

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 quickly, 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:

You will join a cross-functional team designing and developing patient-focused delivery devices. You will lead technical assessments, prototype testing, and risk management while working closely with experts across engineering, formulation, quality, and supply. We value practical problem-solvers who are curious, collaborative, and focused on building safe, reliable, and manufacturable solutions. This role offers clear growth, the chance to shape next-generation device technologies, and meaningful impact aligned with 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 early device development activities from concept through feasibility and engineering confidence testing.

• Perform technology scouting and technical evaluations to identify suitable device solutions.

• Design, prototype, and run lab-based testing and simulations to verify device function, safety, and reliability.

• Identify and drive mitigation for technical, manufacturing and regulatory risks.

• Prepare and maintain core device documentation such as design history files, risk management files, and technical reports.

• Work with internal teams and external partners to support design for manufacturability and scale-up.

• Act as technical lead for the device ensuring Critical Process Parameters are identified, understood, monitored and controlled.

• Actively participate in the investigation team for device and equipment related issues. Lead quality investigations, RCA and CAPA associated with the device.

• Drive the improvement of unit operation process capability and batch yields. Specifically, be accountable for Cost of Goods and Cost of Waste improvements.

• Responsible for delivering key technical activities including NPI trials and planned change implementation.

• Lead/support development work in support of equipment installations and validation.

• Maintain a strong level of validation understanding and proficiencies within life cycle management, including expertise in design controls, manufacturing technologies and upcoming combination products for commercialization.

• Able to perform technical coaching of operators to ensure knowledge transfer to the manufacturing shop floor allowing operators to improve their accountability and timeliness of issue resolution.

• Lead/support risk management activities through the life cycle for devices and conduct periodic risk reviews based on ISO requirements.

• Create/Maintain Device History Files. Provide technical SME input for complaints related to the device

Why You?

We want people who care about patients and practical engineering outcomes. This role is offered as a hybrid position with on-site presence expected for laboratory work, prototype testing and key team activities. Occasional travel may be required.
Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 3 + years of device or medical product experience with hands-on experience using CAD tools for device design and running prototype testing.

• Bachelor's degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering.

• Experience with design controls, risk management and quality processes used in medical device development.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master's degree in engineering or related field and additional device development experience.

• Experience with simulation tools (for example finite element analysis) and in-silico modelling.

• Experience in combination products or drug-device systems, including autoinjectors, pre-filled syringes, or on-body injectors.

• Familiarity with regulatory frameworks and standards relevant to device design, usability, and safety.

• Experience working with contract manufacturers, suppliers, or external partners on prototyping and scale-up.

• Hands-on skills in rapid prototyping, 3D printing, or mechanical test method development.

• Ability to coordinate multidisciplinary work and communicate technical results clearly.

• Proven record of managing multiple tasks and delivering to project timelines.

How to Apply:

We encourage you to apply if this role fits your skills and ambition. Share your resume with a brief note about what excites you about this opportunity and how you can contribute to our team. We look forward to learning more about you.

#LI-GSK

#GSKCareers

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at -usrecruitment.adjustments@gsk.com

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/