Senior Drug Product MSAT Engineer
Core
Senior Drug Product MSAT Engineer supporting equipment selection, qualification, process validation, and technology transfer for biopharmaceutical drug products.
Role type
Senior IC manufacturing sciences and technology engineer
Builds
cGMP-compliant drug product manufacturing processes and equipment systems
Domain
Biopharmaceutical manufacturing / Process Science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
equipment selection and qualification, process validation, technology transfer, cGMP batch documentation review, root cause analysis, process trending and capability analysis, regulatory filing support, raw material and equipment specification, investigation and CAPA implementation
Preferred skills
chemical engineering or biomedical engineering background
Technologies
cGMP batch records, validation protocols, material specifications, master batch records
Responsibilities
Provide drug product manufacturing process knowledge for new product introduction and technology transfer; Act as technical lead for transferring drug product manufacturing processes to facilities; Track and report project milestones for equipment readiness and document creation; Review and approve cGMP batch documentation; Assist with investigation and root cause determination for manufacturing deviations; Trend process performance to establish and improve process capability; Author technical reports and protocols in support of cGMP activities; Support equipment selection, qualification, and start-up activities; Partner with strategic sourcing to specify technical requirements for raw materials and equipment; Support drafting of regulatory filings.
Seniority
Senior, hands-on IC
