MSAT Device Engineer (Injectables)
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 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 The Device Engineer provides technical expertise, guidance, oversight, and support for the associated device assembly, through effective Product Lifecycle Management (PLM) and support for day-to-day operations, to ensure the ongoing manufacture and supply of our products in alignment with Regulatory and Quality standards and business objectives. This role is a key addition to support the new specialty medicine assembly and pack hub at GSK Zebulon.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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. 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. Drive the improvement of unit operation process capability and batch yields. Specifically, be accountable for Cost of Goods (CoGs) and Cost of Waste (CoW) improvements.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor’s Science degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering. 5+ years’ experience in pharmaceutical or biopharmaceutical manufacturing, process development, MSAT or technical operations, with a focus on sterile injectables, especially pre-filled syringe and auto injector formats. Experienced with Product Lifecycle Management, including Control Strategies, Process Qualification, Change Control and Technical Risk Assessments. Required experience working with raw materials, equipment, unit operations and testing for sterile injectables, especially pre-filled syringe and auto injector formats. Commercial Medical Device Assembly experience
Preferred Qualification
If you have the following characteristics, it would be a plus:
Advanced degree in a relevant scientific or engineering field. Proficient in use of technology to communicate and provide reports and analysis of data Awareness of materials and major differences in the manufacturing methods of moulded components e.g. polymers, pigments and the various moulding techniques Awareness/knowledge of Lean/Six Sigma tools Competent knowledge of procurement systems and processes used to drive activities and deliver projects, with a detailed appreciation of compliance requirements Awareness of existing supply base and of the industry in general as a source of new suppliers or specialist skills Awareness/understanding of validation techniques and procedures Knowledge of statistical procedures for data analysis Knowledge of intellectual property considerations Basic understanding of the pharmaceutical regulatory environment and the specific additional legislation needs for medical devices e.g. EC’CE’ marking, FDA Medical Device guidance Basic appreciation of pharmaceutical GMP, pre-approval inspection readiness and company regulatory requirements Basic understanding to enable management of metrology and plastics testing techniques and procedures and GSK Specification and Drawing systems Development of Medical Device Assembly process controls, including creation and/or maintenance of product control strategies Device-Product knowledge Injection Mould Tooling Design and Process Polymer Science Rubber Technology Springs Metal Forming Device Testing Device Assembly/Automation Device Design CAD/CAE Device Supply Base Management Medical Device Regulations RCA/DMAIC Problem Solving
About the Zebulon Site GSK’s Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest. Key differentiators about GSK and Zebulon: Our commitment to inclusion is seen as a critical advantage of ours Our focus on cultivating a positive work environment that cares for our employees Demonstrated opportunities for continued career growth driven by individual ambition Leaders that care about their teams and growth of both individuals and the company A priority focus on Safety and Quality Clean and GMP compliant work environment Onsite cafeteria Onsite gym Temperature-controlled climate Licensed, onsite Health & Wellness clinic
Working arrangement
This role is hybrid. You will be expected to work on-site regularly to support transfers, validations and manufacturing interactions, with flexibility for remote work as agreed with your manager.
Our approach
We welcome people with different backgrounds and perspectives. We seek curious, reliable and collaborative colleagues who want to make a real difference to patient outcomes. If this role matches your skills and ambitions, we encourage you to apply and tell us how you would contribute. #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/
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