The Automation Engineer will be responsible for supporting Quality Assurance, IT and Operations functions with relation to integration of automation, equipment, and networks in a regulated environment. He or she will provide technical oversite and project management for automation-related projects. He or she will act as the liaison and subject matter expert to support internal teams with system integration with the Vernal network and related SaaS applications, as well as coordination of third-party IT services. The Automation Engineer will be responsible for authoring change controls and CSV-related documents, as well as assisting in quality-related investigations. In addition, the Automation Engineer will be responsible for liaising with vendors and assisting with vendor audits.
Key Areas of Focus
- Uses Vernal’s programs to promote high-quality standards and continuous quality improvement
- Provide technical and administrative support for manufacturing and laboratory equipment with respect to automation, controls and integration.
- Industrial PC (IPC) – based systems, Linux and Windows based systems
- Production Systems – barcode reading, vision systems, laboratory systems
- Facilities – building management and environmental monitoring
- Establish and maintain data repositories and data historian for GxP systems, including backup, restoration, and disaster recovery
- Data Connectivity (OPC UA/DA)
- Performance monitoring
- Electronic Batch Records, Electronic Logbooks
- Work with the internal customers to define appropriate user requirements for systems
- Provides guidance and counsel regarding the use of automation and network infrastructure
- Development, approval and/or execution of computer system validation documentation and change controls
- Preventative Maintenance for IPCs and HMIs
- Server Installation (including virtual systems/VMware)
- Ensures compliance with FDA and EMA guidance on data integrity
- Provides back-room support for health authority inspections and customer audits
- Ensures documentation is compliant with Vernal SOPs, formats, and regulatory requirements (protocols, amendments, etc.)
- Reviews associated Vernal SOPs to ensure appropriate application of s
Ensure all equipment, electronic systems and software are in compliance with FDA 21 CFR Part 11 and EMA Annex 11 for Data Integrity
Essential Duties and Responsibilities
- Support quality policy, mission, and vision.
- Provide automation and network expertise to cross-functional teams
- Support the development, documentation, communication, implementation, measurement, and continuous improvement of the systems that make up the overall Vernal Quality System
- Ensure the Vernal Quality System follows applicable federal, state, local, and customer quality requirements (signed TQA)
- Represent the Quality organization in internal discussions
- Mentor team members and partner with other leaders to establish a collaborative and transparent quality culture
- Author and/or approve relevant documents that support automation or validation related activities
- Assist with any commissioning and qualification activities to support GMP Operations.
Desired skills and background
- Bachelor’s degree in a scientific or engineering discipline or equivalent experience required.
- 3-5 years in a similar role
- Background with all Windows operating systems (installation, maintenance, and troubleshooting), Linux, PLC Environments, SCADA systems, ethernet networks, communication protocols and cloud-based technologies
- Cisco certification, fiber infrastructure knowledge and ANSI/ISA-88 beneficial
- GCP/GMP experience in a biotech, pharmaceutical or clinical research organization is beneficial
- Demonstrated ability to participate in cross-functional teams
- Demonstrated ability to work independently, handle multiple tasks simultaneously, and escalate needs to meet critical timelines
- Knowledge of FDA guidelines, and other applicable regulatory requirements
- Excellent organizational, verbal, and written communication skills
- Demonstrated ability to problem-solve and learn
How to Apply
If you feel that you are a great match for this position and want to make a difference in the exciting field of next-generation therapeutics, then reach out to us at [email protected] and be sure to include your resume and cover letter. We look forward to hearing from you!
Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture.
At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA. Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D. Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials. The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA. As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency. We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business. Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance. Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.
Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center. Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:
- Multicultural hub with great schools, restaurants, breweries, shopping, arts, and an affordable cost of living
- Gateway to the Green Mountains including world class hiking, camping, bicycling, and alpine and Nordic skiing