MSAT Device Engineer (Injectables)

GSK•Zebulon, NC

9d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.