What are the responsibilities and job description for the MSAT Process Engineer position at VGXI?
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.
SUMMARY
The Process Engineer works as part of the Process Engineering Section of the MSAT Team to translate technical requirements into tangible infrastructure and scalable processes. The PE section relies on close collaboration with PD, MFG, Facilities, OT, and Quality to bring theoretical optimizations into reality. The Process Engineer will analyze existing processes, identify areas for improvement and implement creative solutions to enhance operational performance. The PE section owns engineering change management as it relates to manufacturing equipment and processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Facilitate technology transfer from PD to MFG
- Identify and implement process improvements to increase compliance, reduce costs, minimize waste and increase efficiency.
- Collaborating with cross-functional teams to ensure smooth integration of new processes, technologies and equipment.
- Monitor and analyze process data, identify trends, and propose solutions for process improvements.
- Collaborate with process development, manufacturing and quality assurance teams to develop and implement standard operating procedures (SOPs) and production documents.
- Provide technical support and troubleshooting expertise to resolve process-related issues
- Support process validation activities, including protocol development, execution and documentation, ensuring compliance with regulatory requirements.
- Responsible for writing and reviewing documents involved in technology transfer of production processes into GMP production in collaboration with VGXI’s client, PD, MFG, QC and QA.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree in engineering or biology, biotechnology, molecular biology, biochemistry, chemistry, bioengineering or closely related field with four or more years in GMP Manufacturing, Process Development, Process Engineering, MSAT or equivalent combination of education and experience.