OverviewThe Manufacturing Science and Technology (MSAT) Engineer 3 provides technical leadership across current good manufacturing practice (cGMP) manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. This role drives technology transfer (TT) of new and existing drug product processes into and between sites, ensuring robust process fit, compliant documentation, and readiness through close collaboration with Process Engineering, Quality Assurance (QA), Quality Control (QC), Supply Chain, and Manufacturing. The Engineer 3, MSAT DPFG provides technical oversight for routine manufacturing operations, including on-floor support, deviation and root-cause investigations, change control, risk assessments, and data-driven performance monitoring, ensuring product quality, compliance, and reliable supply.
External USWhat You'll Do:- Conducts lab and pilot plant experiments
- Generates and coordinates execution sampling protocols
- Serves as subject matter expert (SME), leading and conducting troubleshooting, processing impact assessments, and executing root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
- Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
- Leads and supports technology transfer (TT) across multiple unit operations
- Coordinates, plans, and executes manufacturing process validation runs
- Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
- Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
- Generates and executes process training and consults on topics related to manufacturing and process
- Leads technical risk assessments for new manufacturing processes
- Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
- Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.
- Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab
- Interprets and utilizes new knowledge to promptly drive data-based decisions
- Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
- Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
- Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
- Performs other duties, as assigned
Minimum Requirements:- Associate's degree in Engineering, Life Science or Chemical Engineering with 7 years of applicable industry experience OR
- Bachelor's degree in Engineering, Life Science or Chemical Engineering with 5 years of applicable industry experience OR
- Master's degree with 3 years of applicable industry experience
OR - PhD with no prior experience
- Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
- Experience using risk management and RCA tools
Preferred Requirements:- Experience working in a Good Manufacturing Practices (GMP) environment
- Strong knowledge of regulatory standards and guidance documents for sterile medicinal products
- Prior Drug Product and manufacturing experience, including process development, validation, and transfer
- Experience with drug product formulation, sterile filtration including filter validation, isolator filling equipment, single-use systems, qualifying visual inspection including manual and automated, and validating CCIT methods
