Specialist, Engineering -1
Core
Technical engineering support for sterile fill-finish and lyophilization vaccine manufacturing operations, focusing on in-process analytics, controls, troubleshooting, and equipment validation.
Role type
Specialist, Engineering -1 (cGMP Manufacturing Support)
Builds
Live virus vaccines in a sterile fill-finish and lyophilization facility
Domain
Biopharmaceuticals / Vaccine Manufacturing / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment validation, Root cause analysis, Technical documentation, Process change control, Regulatory compliance, Data analysis, Problem-solving, Change control management, GMP adherence, Equipment troubleshooting
Preferred skills
SAP ME, MES, Delta V, P&ID reading, Lean Six Sigma, Technology transfer, Regulatory inspection experience
Technologies
SAP, MES, Delta V
Responsibilities
Authoring and executing validation protocols, Analyzing complex processing problems, Providing technical support for in-process analytics, Developing scientific justification for process changes, Supporting regulatory filings and inspections, Implementing corrective actions, Supporting critical manufacturing runs
Seniority
Specialist, hands-on IC
