Automation Engineer

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. 

Position Overview:

Beam is looking for a highly energetic Automation Engineer with GMP manufacturing experience focused on supporting automation and control systems including Rockwell PharmaSuite MES, Delta V, Siemens BAS, and Pi. Responsibilities will include design, installation, configuration, validation, and support of existing and future implementations as we progress from clinical to commercial operations.

The candidate will be a core team member for the Engineering and Facilities team developing and maintaining automation systems at the new multi-modality site in Durham / RTP, NC. This is a fantastic opportunity to help continue to develop and grow Beam manufacturing and automation long -term strategy. The successful candidate will show initiative in helping with the development of Beam’s automation strategy, standards, and design criterion to support both commissioned and validated systems for clinical and commercial manufacturing of the current cell and gene therapy manufacturing modality platforms. They will provide technical expertise and assistance in execution of Capital Improvement and Compliance projects. They will also possess the ability to successfully interface with multidisciplinary teams building strong cross functional relationships and engage and collaborate with external partners in IT, supply chain, process development, manufacturing operations, quality, validation, and finance.

Responsibilities:

• Cultivate Beam’s culture and our values-driven organization focused on our people.
• Ensure safety, quality, compliance, efficiency, and sustainability throughout our engineering, automation, and cGMP operations.
• Project support for PharmaSuite MES on new and existing lines within manufacturing.
• Provide technical oversight to development and deployment of MES Electronic Batch Record (EBR).
• Support development and lifecycle management of automation systems including PharmaSuite, DeltaV and PI.
• Collaborate with cross-functional team of business partners to ensure integration of PharmaSuite with existing computerized systems including LIMS, SAP, PIMS.
• Foster a continuous improvement culture through identification and adoption of process improvements, both in EBR design and MES support processes.
• Provide ongoing support, maintenance, and continuous improvement for automation systems (MES, PCS, PI).
• As part of the engineering team, further develop and execute the long-range Automation and MES strategy.
• Develop and Maintain Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for automation systems.
• Assist in the development and execution of Automation Capital Engineering projects for facility, operational, site, and process improvement projects.
• Ensure compliant operations in accordance with site registrations, cGMP, environmental regulations, and federal / state requirements.
• Proactively analyzes engineering and facility issues and coordinates potential resolutions with the team.

Qualifications:

• BS degree in a technical discipline (Engineering preferred) with a minimum of 10+ years of relevant experience.
• 3+ years of experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PharmaSuite or similar MES.
• Experience in biotechnology / pharmaceutical / medical device manufacturing environment.
• Experience in DeltaV DCS, and Aveva PI preferred.
• Knowledge of GMP reporting, batch record generation, reports from data historian / historical data, and support of deviation or CAPA investigations (preferred).
• Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (e.g.GAMP5, FDA 21 CFR Part 11).
• Capital project, start-up, and manufacturing support experience.
• Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management.
• Previous experience with Agile or LEAN.
• Ability to manage commitments for self while displaying an eagerness to learn and continuously improve.
• Ability to work on multiple projects and manage various priorities and timelines and to adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, ownership, and drive.