Gsk
Pharmaceutical
MSATDeviceEngineer(Injectables)
“MSAT Device Engineer (Injectables) at Gsk. Skills: Device assembly, Injectables manufacturing, Product Lifecycle Management. Act as technical lead. Identify Critical Process Parameters”
What You'll Achieve.
Ensure ongoing manufacture; Ensure ongoing supply; Improve accountability; Improve timeliness issue resolution; Cost of Goods improvements; Cost of Waste improvements
Industry & Context.
Root cause analysis; CAPA; Risk management; Problem solving
What They're Looking For.
Must Have
Bachelor's Science degree, 5+ years experience pharmaceutical manufacturing, 5+ years experience process development, 5+ years experience MSAT, 5+ years experience technical operations, Experience sterile injectables, Experience pre-filled syringe formats, Experience auto injector formats, Experienced with Product Lifecycle Management, Experienced with Control Strategies, Experienced with Process Qualification, Experienced with Change Control, Experienced with Technical Risk Assessments, Required experience raw materials, Required experience equipment, Required experience unit operations, Required experience testing sterile injectables, Required experience pre-filled syringe formats, Required experience auto injector formats, Commercial Medical Device Assembly experience
Nice to Have
Advanced degree relevant field, Proficient use technology communicate, Proficient use technology provide reports, Proficient use technology analysis data, Awareness moulded components materials, Awareness moulded components manufacturing methods, Awareness Lean tools, Awareness Six Sigma tools, Competent knowledge procurement systems, Competent knowledge procurement processes, Awareness existing supply base, Awareness industry new suppliers, Awareness industry specialist skills, Awareness validation techniques, Awareness validation procedures, Knowledge statistical procedures, Knowledge intellectual property considerations, Basic understanding pharmaceutical regulatory environment, Basic understanding medical device legislation, Basic appreciation pharmaceutical GMP, Basic appreciation pre-approval inspection readiness, Basic understanding metrology techniques, Basic understanding plastics testing techniques, Basic understanding GSK Specification systems, Basic understanding GSK Drawing systems, Development Medical Device Assembly process controls, Device-Product knowledge, Injection Mould Tooling Design, Injection Mould Tooling 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
What You'll Do.
Act as technical lead
Identify Critical Process Parameters
Understand Critical Process Parameters
Monitor Critical Process Parameters
Control Critical Process Parameters
Participate in investigation team
Lead quality investigations
Deliver key technical activities
Support planned change implementation
Lead development work
Support equipment installations
Maintain validation understanding
Maintain validation proficiencies
Perform technical coaching operators
Ensure knowledge transfer
Improve accountability
Improve timeliness issue resolution
Lead risk management activities
Support risk management activities
Conduct periodic risk reviews
Create Device History Files
Maintain Device History Files
Provide technical SME input
Drive improvement unit operation process capability
Drive improvement batch yields
Improve Cost of Goods
Improve Cost of Waste
How You'll Work.
Team & Collaboration
Investigation team; Manufacturing shop floor
Communication Scope
Provide reports; Analysis of data
Process & Methodology
Change Control, Technical Risk Assessments
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