ABOUT VGXI INC

VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers. 

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

Lead, develop and support the implementation of multiple automation and process control solutions, focused on manufacturing equipment, manufacturing supporting systems and technologies utilizing applicable Distributed Control Systems (DCS), Supervisory Control and Data Acquisition systems (SCADA), Environmental Monitoring Systems (EMS) and Building Management Systems (BMS), following regulations, good automation manufacturing practices and related industry standards.

In addition, support capital projects and functional area projects by providing technical guidance during commissioning, qualification and operational readiness activities requiring process control and data acquisition solutions.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Develop and implement process control and automation solutions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
• Lead the integration, programming and automation testing of:
• • Manufacturing preparation and process equipment including autoclaves, washers, fermenters, lysis\depth filtration and UFDF skids, between others.
  • Manufacturing supporting systems including Buffer/Media prep, CIP and SIP systems.

• Lead the development and programming of recipe-controlled process steps, batch operations and manufacturing historical data and reporting solutions.
• Develop and maintain automation system’s documentation including design specification, functional specification and system administration procedures, in alignment with industry standards.
• Lead day-to-day operational support including 24 x 7 onsite/on call support and troubleshooting activities involving automated equipment and process control systems.
• Perform automation system administration duties including applications and operating system (OS) Hotfixes assessments and rollout.
• Supports installation, configuration, and maintenance of the process control networks, servers and workstations, including upgrades, security and network topology.
• Support spare parts management for automation systems and its critical components.
• Support functional area projects requiring automated operations of process equipment, utilities systems, facilities and sophisticated unit operations including drug product manufacturing technologies, for clinical to commercial facility.
• Collaborate with subject matter experts (SMEs) to understand key process requirements and develop automation solutions to improve manufacturing operations, workflows and productivity.
• Support Quality Assurance with technical root cause analysis, incident investigations, and solving problems related to process control issues within manufacturing operations.
• Support Facilities and Engineering area with site automated control needs.
• Support strategies for robust establishment of industrial automation best-practices following ISA/IEC, ISO, GAMP and IEEE standards among others.   
• Support the implement of strategies adhering to FDA cGMP and EU Annex 21 regulations including but not limited to 21 CFR Part 11, 210 and 211 (ERES, Data integrity, ALCOA), and Annex 1, 11 regulations.
• Other related duties as assigned.

EDUCATION and/or EXPERIENCE

Bachelor's degree in electrical, mechanical or chemical engineering from a credited college or university and four years related experience and/or training; or equivalent combination of education and experience.

BENEFITS

At VGXI, we recognize that our employees are at the heart of our success, and we offer exceptional benefits that reflect our commitment to their well-being. Our comprehensive offerings include a range of quality benefits, available to our employees from day one (no waiting period). Benefits include:

• Medical
• Dental
• Vision
• Life Insurance
• Short-Term and Long-Term Disability
• 401K Plan
• Flexible Spending Account
• Tuition Reimbursement
• Paid Time Off Including Holidays, Vacation and Sick/Personal Leave.

DIVERSITY, EQUITY AND INCLUSION

At VGXI, we are committed to recognizing and valuing you. Our diverse backgrounds, perspectives, and contributions fuel innovation and allow us to success both as individuals and as a team. We have established and embrace a culture of acceptance and inclusion with equity in recruiting, hiring, developing, and investing in talented people. Our commitment to these principles supports a diverse workforce and empowers us to achieve our mission of leading the industry in producing the next generation of therapeutics to improve patients’ lives.

Equal Opportunity Employer