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