Job Summary: As a Process Engineer specializing in Single-Use (SU) equipment, you will play a crucial role in designing, optimizing, and troubleshooting processes utilizing SU technologies, with a particular focus on Tangential Flow Filtration (TFF), Chromatography (Chrome), SU mixers, and Liquid Nitrogen (LNP) equipment. You will be responsible for SU component design, recipe design and testing, modification of existing parts/assemblies, troubleshooting process equipment, and ensuring compliance with change control, deviation, and CAPA processes. Strong communication skills are essential for collaborating with stakeholders and vendors to create and modify flow paths, as well as for informing stakeholders of process changes and troubleshooting outcomes.

Responsibilities:

• Single-Use Equipment Expertise:

• Utilize expertise in TFF, Chrome, SU mixers, and LNP equipment to design, optimize, and troubleshoot processes

• Collaborate with vendors and internal teams to design SU components and create flow paths for new and existing processes

• Create and modify custom parts, flow paths, and assemblies to meet process requirements and improve efficiency

• Recipe and Design Testing:

• Develop and test recipes for SU equipment, ensuring optimal performance and product quality

• Conduct experiments and analyze data to optimize recipe parameters and process conditions

• Troubleshooting and Problem-Solving:

• Independently troubleshoot process equipment issues and implement corrective actions to minimize downtime and maintain production continuity

• Utilize analytical skills and technical expertise to diagnose root causes of process deviations and equipment failures

• Communication and Stakeholder Management:

• Communicate effectively with stakeholders, including vendors, cross-functional teams, and management, to coordinate SU component design, modification, and implementation

• Provide timely updates on process changes, troubleshooting efforts, and project status to stakeholders

• Change Control, Deviation, and CAPA:

• Manage change control processes for process modifications and equipment changes, ensuring compliance with regulatory requirements

• Investigate deviations and non-conformances, develop corrective and preventive actions (CAPAs), and implement solutions to prevent recurrence

• Fill/Finish Experience (Nice to Have):

• Utilize experience in fill/finish operations to support process optimization and troubleshooting efforts as needed

Qualifications:

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related field (Master's degree preferred)

• 5+ years of experience in process engineering, with a focus on single-use equipment, preferably in the pharmaceutical or biotechnology industry

• Proficiency in designing and troubleshooting SU equipment, including TFF, Chrome, SU mixers, and LNP equipment

• Strong understanding of change control, deviation, and CAPA processes, with experience implementing corrective and preventive actions

• Excellent communication skills, with the ability to collaborate effectively with internal teams, vendors, and stakeholders

• Experience in fill/finish operations is a plus