Associate Process Engineer, MS&T
Core
Entry-level technical contributor supporting the implementation and sustainment of biopharmaceutical equipment and processes for gene therapy manufacturing.
Role type
Associate Process Engineer (Drug Product)
Builds
Gene therapy manufacturing processes and equipment readiness
Domain
Biopharmaceuticals / Gene Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment performance evaluation, process parameter optimization, technical documentation authoring, technology transfer support, commissioning and qualification, equipment troubleshooting, regulatory compliance (FDA/EMA/ICH), GMP documentation
Preferred skills
Biologics or gene therapy manufacturing experience, electronic documentation systems, data analysis tools
Technologies
P&IDs, URS, FAT, SAT, IQ/OQ
Responsibilities
Support execution of engineering studies to evaluate equipment performance and optimize process parameters. Assist with authoring and revising technical documentation including SOPs, protocols, and reports. Support technology transfer activities including process flow mapping and risk assessments. Support commissioning and qualification activities including vendor IQ/OQ and site acceptance testing. Support equipment troubleshooting and vendor interactions. Provide technical support to Manufacturing for routine operations and new process implementation. Support investigations related to process or equipment performance and assist with corrective actions. Ensure processes meet regulatory guidelines and quality system requirements.
Seniority
Entry level
