Senior Engineer I, Manufacturing Sciences
Core
Provide hands-on process and manufacturing sciences expertise to support technology transfers, PPQs, and complex manufacturing investigations for parenteral drug products.
Role type
Senior IC manufacturing sciences engineer (biologics/parenterals)
Builds
Biopharmaceutical manufacturing processes and parenteral drug products
Domain
Biopharmaceuticals / Parenteral drug manufacturing
Required skills
Manufacturing sciences expertise, Biologics process knowledge, Data analysis (Tableau, Power BI, Statistica, SIMCA), SOP development, Technology transfer support, CAPA leadership, Regulatory filing support, Cross-functional collaboration
Preferred skills
Regulatory activity support, Strategic business process optimization, Complex manufacturing investigation leadership
Technologies
Tableau, Power BI, Statistica, SIMCA
Responsibilities
Provide on-site technical leadership during live manufacturing operations, Lead rapid process impact assessments and CAPAs, Engage with Manufacturing/Quality/Engineering to execute SOPs and batch records, Review and trend manufacturing campaign data, Support technology transfers from development/partners, Develop tests to ensure process execution, Identify optimization initiatives for productivity and robustness, Coordinate technical reports for deviations and transfers, Serve as SME in biopharmaceutical manufacturing, Support regulatory filings, inspections, and audits (via careerplan.io/jobs/REQ24003-senior-engineer-i-manufacturing-sciences-at-biibhr)
Seniority
Senior, hands-on IC