Senior Engineer II

Senior Engineer II

Requirements

• Requires a Master’s degree in Biomedical Engineering, Biochemical Engineering, Biotechnology or related field and eight (8) years of experience in the position offered or as a Technical Development Engineer, Biochemical Engineer, Scientist, Specialist or related position.
• Alternatively, employer will accept a Bachelor’s degree in fields specified and ten (10) years of the specified progressive, post-baccalaureate experience.
• Must have at least 8 years of experience with:
• Technical transfer of new process and introduction of new manufacturing equipment;
• Manufacturing support and troubleshooting of drug substance manufacturing processes and equipment during production of batches;
• Chromatography, Tangential flow filtration (TFF) system, fill finish operations, columns, column packing, spectrophotometers, Optical density meters, conductivity meters, pumps, valves, and filtration systems;
• Six sigma tools, statistical and data analysis using JMP;
• Change management and deviation support using quality management systems and cGMP guidelines using VEEVA;
• Authoring Standard Operating Procedures, User Requirement Specification (URS), Risk Assessments and Product Impact Assessments applying technical knowledge of drug substance manufacturing and equipment for drug substance manufacturing; and
• Visio, SAP, and automation software in manufacturing.

Responsibilities

• Lead technical transfer and new process implementation to ensure the robust production of mRNA and lipid nanoparticle (LNP) drug substances using current Good Manufacturing Practices (cGMP).
• Work collaboratively with cross functional stakeholders including technical development, manufacturing, automation, regulatory, and quality, to ensure all technical aspects of the process are successfully implemented.
• Collaborate with technical development and process development of mRNA and LNP on material generation for Investigational New Drug (IND) enabling studies.
• Provide technical support and serve as the subject matter expert for drug substance manufacturing, including supporting equipment commissioning, process transfer, automation recipe implementation, troubleshooting and leading technical investigations.
• Perform process monitoring, analysis, implementation, and troubleshooting for new process in a validated state using statistical software PI Process book and JMP for creating and analysis of trends.
• Perform engineering runs and execute on-floor testing/troubleshooting using biomanufacturing instruments such as Spectro-photometers, Optical Density-meters, conductivity meters, pumps and filtration systems, chromatography, tangential flow filtration (TFF), columns and column packing, and AKTA purification system.
• Collaborate cross functionally on technical deviations and represent as a subject matter expert for drug substance operations on product and process deviations.
• Provide engineering support for projects for drug substance manufacturing, including the definition of project scope, option analysis, engineering design, execution, and qualification.
• Create engineering documentation such as URSs and Design Specifications.
• Author process and equipment risk assessments to support drug substance manufacturing.
• Provide on-call support for drug substance manufacturing.
• Support process training for GMP operations and development of process understanding and expertise.
• Lead and participate in cross-functional teams to improve business practices and drive operational efficiency and effectiveness.
• Provide technical leadership, mentoring, and coaching of junior department staff.
• Communicate with leadership to drive alignment of critical decisions, strategy, and risk mitigations.
• Support sections of regulatory filings and assist in change control management.

Preferred Qualifications

No preferred qualifications provided.