Process Engineer

Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.

This position is a Subject Matter Expert in Biologics manufacture providing process input and support to capital projects throughout the Lonza network.

* Assist with conceptual studies & throughput opportunities. Works closely with manufacturing sites to evaluate design robustness, equipment selection and operability. * Assist with cost estimating, scheduling and specification tools which enable fast turn around and accuracy in conceptual estimating. * Provide data based models to enable evaluation of designs at all stages of project lifecycle. * Responsible for some or all aspects of Project Engineering/Management within project lifecycle. This may include drafting and submitting ESR and CAR documents and project management of concept studies. * Contribute to multi-disciplinary project teams to support and/or execute project deliverables related to all project phases including conceptual, basic design, detailed design, FAT, SAT, Construction, Start-up, Commissioning, IQ, and/or OQ to the level of quality expected by Lonza * Ability to interact with all levels of the organization from plant floor to senior management and the ability to prepare and present information clearly to senior management or customer representatives. **Safety** Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. **Quality Responsibility** Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. **Mental Demands** Ability to develop abstract ideas into applications and multitask a high number of priorities.

**Education** * High School Diploma or Equivalent; BS or greater * Preferred area of study: Engineering (Chemical or Mechanical), Biologics related field **Experience** * 5+ Years relevant experience * Licenses or Certifications **Knowledge** * Expertise in modeling software preferred, knowledge of industry trends, knowledge of regulatory trends **Skills** * A Subject Matter Expert in the design required for facilities which manufacture mammalian/CT/VT. * Inoculum strategies * Cell culture scale up (including single use platforms) * Downstream processing (Chromatography, TFF, VRF, ILD) * Current regulatory demands * 2D and 3D Cell therapy platforms * Technical understanding of Viral Therapies from conceptual perspective * Understanding of formulations for Media and buffers where available